Procedural Advice on CHMP_CAT Rapporteur_co-rapporteur

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© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.

09 March 2010 EMA/151751/2010 (Previously EMEA/124066/2005 Rev 2) Committee for Medicinal Products for Human Use (CHMP)

Procedural Advice on CHMP/CAT rapporteur/co-rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) NO 726/2004

Adoption by CHMP September 2006

Discussion at CAT (revision 1) July 2009

Discussion at CHMP July 2009

Adoption by CAT September 2009

Adoption by CHMP September 2009

Adoption by CHMP (revision 2) March 2010

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Table of Content Executive Summary ......................................................................................................3

1. Introduction..............................................................................................................4

1.1. Legal Framework on Rapporteur/Co-Rapporteur appointment ..............................4

1.2. Scope of this Paper ................................................................................................5

1.3. Overview of the Procedure.....................................................................................6

2. Principles to be considered on the appointment of Rapporteur and Co-Rapporteur and

their assessment teams ................................................................................................7

3. CHMP Objective Criteria on the appointment of Rapporteur/Co- Rapporteur and their

assessment teams ........................................................................................................9

3.1. Assessment Team Objective Criteria ......................................................................9

3.2. Individual Objective Criteria ................................................................................10

3.3. In case of proposed assessment teams with similar objective criteria (scientific

competence and availability), the following criterion will be used:.............................10

3.4. Choice between Rapporteur and Co-Rapporteur ..................................................10

4. Methodology on the appointment of Rapporteur/Co- Rapporteur and their assessment

teams..........................................................................................................................11

4.1. First Phase ...........................................................................................................11

4.2. Second Phase.......................................................................................................12

4.3. Changes affecting the appointment of Rapporteur/Co-Rapporteur ......................14

5. Appointment of Rapporteur/ Co- Rapporteur for other procedures.........................16

5.1. Re-examination of a CHMP opinion ......................................................................16

5.2. Referrals ..............................................................................................................18

5.3. Generics/Hybrids and Similar biological medicinal products................................21

5.4. Similar biological medicinal products...................................................................24

5.5. Non-prescription medicinal products…………………………………………………………....30

References..................................................................................................................28

Abbreviations..............................................................................................................28

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Executive Summary The Pharmaceutical legislation (Regulation (EC) No 726/2004) provides the legal framework for the Rapporteur /Co-Rapporteur appointment. The CHMP Rules of Procedure (EMEA/CHMP/111481/2004) and the Notice to Applicants (Chapter 4) further elaborate on the appointment of CHMP Rapporteurs and Co-Rapporteurs. In addition, the CAT Rules of Procedures (EMEA/CAT/454446/2008) and the procedural advice on the evaluation of ATMPs further elaborate on the appointment of CAT Rapporteurs and Co-Rapporteurs in the case of Advanced Therapy Medicinal Products (ATMPs).

This Paper sets the principles, objective criteria and the methodology on the Rapporteur/Co-Rapporteur and their assessment teams’ appointment procedure. These principles and objective criteria shall apply to several application types (e.g. centralised applications, applications on Article 58 of Regulation (EC) No 726/2004, compassionate use).

• Additional principles for the Rapporteur/Co-Rapporteur appointment are presented for other type of application procedures, such as:

• Generics/Hybrids • Similar Biological medicinal products • Referrals and • Re-examination of a CHMP opinion

The appointment procedure for Rapporteur/Co-Rapporteur and their assessment teams is initiated 7 months prior to the Marketing Authorisation Application (MAA) submission intended date, to allow the actual Rapporteur/Co-Rapporteur appointment 6 months prior to the MAA intended submission date.

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1. Introduction 1.1. Legal Framework on Rapporteur/Co-Rapporteur appointment

• Appointment of Rapporteur/Co-Rapporteur

The appointment by the CHMP of Rapporteur/Co-Rapporteur is made in accordance with Article 62(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, which states:

“Where, in accordance with the provisions of this Regulation, the Committee for Medicinal Products for Human Use, the Committee on Herbal Medicinal Products or the Committee for Medicinal Products for Veterinary Use is required to evaluate a medicinal product, it shall appoint one of its members to act as rapporteur for the coordination of the evaluation. The Committee concerned may appoint a second member to act as co-rapporteur.”

Regarding the alternate Members, Article 61(1) of the same Regulation states:

“…The alternates shall represent and vote for the members in their absence and may act as rapporteurs in accordance with Article 62”.

Article 57(1) of the same Regulation states that the Agency [and therefore its Scientific Committee(s) Members] shall provide the best possible scientific advice: “The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.” In addition, the CHMP Rules of Procedure (EMEA/CHMP/111481/2004) state in Article 6.1 on the appointment of Rapporteur: “For any scientific evaluation in respect of a procedure a rapporteur shall be appointed from amongst the members of the Committee or alternates. The appointment of the rapporteur shall be made on the basis of objective criteria, which will allow the use of the best available expertise in the EU on the relevant scientific area.“ In addition, the CAT Rules of Procedures (EMEA/CAT/454446/2008) state in Article 5 on the CAT Rapporteur, Co-Rapporteur and Assessment Team: “For any scientific evaluation of an ATMP, CHMP shall appoint two evaluation teams, including, respectively, a CAT Rapporteur or CAT Co-Rapporteur from amongst the members or alternates of the CAT, together with the Assessment Team members. Such appointment shall be made on the basis of objective criteria, which allows the use of the best available expertise in the EU on the relevant scientific area of advanced therapies.”

• Task in providing objective scientific opinions

In accordance with Article 61(5) of the same Regulation, the Members of the Committee (and therefore the appointed Rapporteur/Co-Rapporteur) have the task in providing objective scientific opinions:

“In addition to their task of providing objective scientific opinions to the Community and Member States on the questions which are referred to them, the members of each committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorisation.”

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Scientific evaluation and resources Article 61(6) of the same Regulation states with regard to the scientific evaluation and resources: “Members of the committees and experts responsible for evaluating medicinal products shall rely on the scientific evaluation and resources available to national marketing authorisation bodies. Each competent national authority shall monitor the scientific level and independence of the evaluation carried out and facilitate the activities of nominated committee members and experts. Member States shall refrain from giving committee members and experts any instruction which is incompatible with their own individual tasks or with the tasks and responsibilities of the Agency.” In addition, the CHMP Rules of Procedure (EMEA/CHMP/111481/2004) state in Article 6.4: “The rapporteur, and when appropriate, co-rapporteur chooses amongst the experts included in the European experts list available at the EMEA, those who will form his/her/their assessment team. He/she/they notify his/her/their choice to the EMEA prior to the start of the procedure. Members of the Committee or alternates and experts responsible for the evaluation of applications shall rely on the scientific evaluation and resources made available by national competent authorities and the EMEA.”

• Written contact, remuneration

The provision of services by rapporteurs is made in accordance with Article 62(3) of the same Regulation, which states: “The provision of services by rapporteurs or experts shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and his employer. The person concerned, or his employer, shall be remunerated in accordance with a scale of fees to be included in the financial arrangements established by the Management Board.” This issue is also outlined in Article 6.7 of the CHMP Rules of Procedure (EMEA/CHMP/111481/2004).

• Call for an expression of interest

Article 62(4) of the same Regulation states with regard to the call for an expression of interest:

“The performance of scientific services for which there are several potential providers may result in a call for an expression of interest, if the scientific and technical context allows, and if it is compatible with the tasks of the Agency, in particular to ensure a high level of public health protection. The Management Board shall adopt the appropriate procedures on a proposal from the Executive Director.”

This issue is also outlined in Article 21 of the CHMP Rules of Procedure (EMEA/CHMP/111481/2004).

1.2. Scope of this Paper

The scope of this Paper is to set the principles, objective criteria and the methodology on the Rapporteur/Co-Rapporteur and their assessment teams’ appointment procedure. The principles and objective criteria on Rapporteur/Co-Rapporteur and their assessment teams appointment shall apply to several application types (e.g. centralised applications, applications on Article 58 of Regulation (EC) No 726/2004, compassionate use). Additional principles for the appointment of Rapporteur/Co-Rapporteur and their assessment teams for other type of application procedures are also presented in this Paper [for instance, re-examination of a

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CHMP opinion, referrals, generics, hybrids, similar biological medicinal products, non-prescription medicinal products]. The roles and responsibilities of a CHMP Member are outlined in detail in the CHMP Rules of Procedure (EMEA/CHMP/111481/2004, adopted by the CHMP in September 2004). The role and responsibilities of a CAT Member are outlined in detail in the CAT Rules of Procedure (EMEA/CAT/454446/2008) and in the procedural advice on evaluation of ATMPs. It should also be noted that the CHMP has established a peer review procedure. Such procedure foresees the appointment of peer reviewers during the initial phase of the assessment of new MAAs. Such appointment is made on a voluntary basis. For ATMPs, there will be a peer review coming from CAT and CHMP.

1.3. Overview of the Procedure

In order to obtain the optimum performance of scientific services and to make use of best and available expertise in the EEA (European Economic Area), a two-phase approach is envisaged for the Rapporteur/Co-Rapporteur and their assessment teams appointment process:

• First phase The first phase is an early preparatory step and will act as an indicator for the subsequent appointment of Rapporteur/Co-Rapporteur and their assessment teams (to be appointed in the second phase). At this first phase the EMA will inform EEA National Competent Authorities (NCAs)1, CHMP Members and CAT Members (only for ATMPs) on planning estimates of forthcoming applications and their related therapeutic and (new) technological areas. NCAs/CHMP/(CAT) Members will be asked to indicate their interest and scientific competence and resources on these future applications. The objective criteria outlined in Section 3 of this Paper could be considered by the NCAs/CHMP Members in order to assert /confirm their interest and competence. The benefits of this first phase would be to:

o Indicate scientific competence related to specific therapeutic/technological area(s)

o Stimulate proactive and longer term scientific resource planning o Identify potential difficulties and facilitate resolutions in allocation of scientific

expertise (capacity/competence) in particular (new) therapeutic/technological area(s)

o Build an overall profile of the capacity and system in place for scientific assessment resources in certain therapeutic/technological area(s), if desired by the NCAs

• Second phase At this phase the Rapporteur/Co-Rapporteur and their assessment teams appointment shall take place.

A detailed methodological overview of the first and second phase is outlined and discussed in Section 4 (Methodology) of this Paper.

1 This information will be forwarded to the Heads of Agencies of the EEA NCAs.

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2. Principles to be considered on the appointment of Rapporteur and Co-Rapporteur and their assessment teams The following principles shall be considered on the appointment of Rapporteur/ Co-Rapporteur and their assessment teams:

• For any scientific evaluation in respect of a procedure a Rapporteur and if relevant a Co-Rapporteur shall be appointed2.

• All CHMP Members (including co-opted members) and alternates can act as Rapporteur/Co-

Rapporteur. Therefore, CHMP Members and alternates are invited to indicate in writing their interest regarding certain Rapporteur/Co-Rapporteurhip(s).

• For ATMPs, all CAT Members and alternates can act as Rapporteur/Co-Rapporteur.

Therefore, CAT Members and alternates are invited to indicate in writing their interest regarding certain Rapporteur/Co-Rapporteurhip(s). In this instance, CHMP members (including co-opted members) and alternates can indicate their interest as CHMP Co-ordinator.

• The appointment of the Rapporteur/Co-Rapporteur shall be made on the basis of objective

criteria, which will ensure the provision of objective scientific opinions and will allow the use of the best and available expertise in the EEA in the relevant scientific area, over the lifecycle of the medicinal product.

• The Rapporteur/Co-Rapporteur shall be supported by a team of assessors/experts

(assessment team) during the various phases of the assessment of the application.

• The resources of the Rapporteur/Co-Rapporteur’s assessment team shall be assessors/experts available not only from the Rapporteur/Co-Rapporteur NCAs’ level, but could be available from across the EEA. These assessors/experts should be chosen from the European Experts DataBase.3

• In the pre-authorisation phase of the Marketing Authorisation Application (MAA), two Rapporteurs (i.e. a Rapporteur and a Co-Rapporteur) shall be appointed2. In the case of an ATMP, a CAT Rapporteur, a CAT Co-Rapporteur and two CHMP Co-ordinators (one from each team) shall be appointed.

• Normally, the Rapporteur (and her/his assessment team) would be the leader in the

centralised post-authorisation phase2. The assessment team is likely to be revised and or complemented in order to accommodate additional input needed on Pharmacovigilance/Risk Management expertise.

• The role of the Rapporteur/Co-Rapporteur2 is mainly to:

o Take responsibility for the scientific assessment/evaluation undertaken by the team for the quality, efficacy and safety related aspects of the medicinal product in accordance to the timeframes laid down in the EU legislation and the EMA regulatory procedures

o Coordinate input from her/his assessment team o Coordinate input from a variety of fora e.g. Working Parties, Ad Hoc Expert Groups,

SAGs (Scientific Advisory Groups), external meetings/conferences o Involve additional expertise as considered necessary, e.g. specialised expertise in

Pharmacovigilance and Risk Management o Provide objective scientific opinions (positive/negative) and a scientifically justifiable

SPC and PL on a given application o Identify proposed conditions of use of the medicinal product o Identify post-authorisation measures to ensure and monitor the safe and effective use

of the product after authorisation o Act as a CHMP representative/spokesman in liaison with Applicant/MAH

2 The involvement of the Co-Rapporteur is deemed necessary in: a) the centralised pre-authorisation phase b) the assessment of a Type II variation application concerning new indication(s) c) renewals of centrally authorised medicinal products and d) referral procedures. The involvement of the Co-Rapporteur in other variations/post-authorisation procedures will be agreed by the CHMP on a case-by-case basis. See also, outline of exceptional cases in section 4.3 of this Paper. 3 If new experts are needed, they must be added in the European Expert DataBase, following the standard procedure.

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o Interact in the best possible way with the PTL/PTM o Implement the outcome of the peer review in a critical and transparent manner o Ensure that all her/his activities are performed in a transparent manner (informing

accordingly the EMA Secretariat) o Establish contacts with Patient Organisations/Health Care Professional Associations (in

accordance with the provisions laid down in Article 78.2 of Regulation (EC) No 726/2004)

o For ATMPs, the role of the CAT Rapporteur/ CAT Co-Rapporteur2 is the same as

described above except that the CAT Rapporteur/ CAT Co-Rapporteur provide objective scientific draft opinions (positive/negative).

• For ATMPs, the role of the CHMP Co-ordinators is mainly to:

o Ensure the continuous flow of information between CAT and CHMP o Facilitate product presentation at CHMP (e.g. issues arising from Day 120 LoQ, Day

170 LoOI) and guide the final CHMP discussion at the time of adoption of the opinion. o Provide input as required in the assessment of the ATMPs (comments on the

assessment report, the List of Questions (LoQ), the joint assessment report and the List of Oustanding Issues (LoOI))

o Interact in the best possible way with the PTL/PTM o Provide objective scientific opinions (positive/negative) and a scientifically justifiable

SPC and PL on a given application o Identify proposed conditions of use of the medicinal product o Identify post-authorisation measures to ensure and monitor the safe and effective use

of the product after authorisation o Act as a CHMP representative/spokesman in liaison with Applicant/MAH o Ensure that all her/his activities are performed in a transparent manner (informing

accordingly the EMA Secretariat)

• The Applicant's proposals/preferences will not be considered for the appointment of Rapporteur/Co-Rapporteur4.

• The appointment of Rapporteur/Co-Rapporteur for a procedure should be independent of

another procedure involving the same active substance/medicinal product (e.g. appointment as Co-ordinator for Scientific Advice for the same substance/medicinal product or Rapporteur/Co-Rapporteur appointed for a medicinal product within the same therapeutic area).

• The CHMP Chairman will decide on the final Rapporteur/Co-Rapporteur and their assessment

team appointment and will propose it to the Committee. Such proposal involves CAT Chairman for ATMPs.

• The Rapporteur/Co-Rapporteur and their assessment teams are bound to the EMA Rules on the

Public Declaration of Interests and Confidentiality Undertaking.

4 Explicit reference to proposals from the Applicant for the choice of Rapporteur/Co-Rapporteur is no longer made in the Legislation (Regulation (EC) No 726/2004 of the European Parliament and of the Council).

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3. CHMP Objective Criteria on the appointment of Rapporteur/Co- Rapporteur and their assessment teams

The appointment of Rapporteur/Co- Rapporteur and their assessment teams shall be made on the basis of objective criteria, which will ensure the provision of objective scientific opinions and will allow the use of the best and available expertise in the EEA in the relevant scientific area. The objective criteria outlined in this Paper are identified as:

• Ability of Rapporteur/Co- Rapporteur to fulfil their role, which refers mainly to their ability to take responsibility for the scientific assessment /evaluation undertaken by the assessment team, coordination input etc (please see outline of the Role of Rapporteur/Co- Rapporteur in Section 2 of this Paper).

• Assessment Team Objective Criteria which refer to the scientific competence, regulatory experience, complementary cross-team scientific expertise and competence of the Assessment Team(s) as well as the availability of an adequate Quality Assurance System at the level of the EEA NCAs.

• Individual Objective Criteria5 which refer to the academic expertise and the direct working experience and competence of the:

Individual assessor/expert Rapporteur/Co-Rapporteur (when acting as assessor/expert in the scientific

assessment of the application)

3.1. Assessment Team Objective Criteria

The following Assessment Team objective criteria shall be taken into consideration on the appointment of the Rapporteur/Co-Rapporteur assessment team(s):

• Scientific competence of the team(s) in the handling of particular aspects6 of the

MAA, such as:

o Methodological/statistical aspects

o Risk management/pharmacovigilance aspects

o Environmental risk toxicity

• Regulatory experience, such as:

o Experience in the review of dossiers, preparation and provision of assessments reports for central and/or national MAAs in the relevant scientific area

o Ability to deliver assessment reports on time, and in accordance with the templates

and the timetables agreed and adopted by the Committee, and/or specified for the particular procedure(s) as defined in the European Pharmaceutical Legislation

o Experience in peer review of CHMP/CAT Assessment Reports/Lists of Questions o Experience with non-prescription medicinal products assessment; Experience with

changes in legal status; Involvement at national level with same active substance(s) or rest of the therapeutic class as a non-prescription medicinal product coming for a central application; Experience in communication with patients

• Sufficient cross-team complementary expertise:

5 The main criteria are the overall competence (scientific/regulatory) of the team to handle the scientific assessment and the Quality Assurance System of the NCA. 6 In addition to the scientific competence aspects considered in the quality, safety and efficacy of a MAA.

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Individual Objective Criteria shall be taken into consideration on the appointment of Rapporteur/Co-Rapporteur and their assessment team(s) (please see Section 3.2 of this Paper). The need for additional input from (external/internal) assessors/experts during the assessment and/or in the post-authorisation phase should be transparent and their scientific/regulatory competence should be ensured, since they will be part of the assessment team (see also Section 2 of this Paper, Principles).

• Quality Assurance System (QAS)

Availability of an adequate QAS that ensures the optimal quality of the scientific assessment and also regulatory consistency.

3.2. Individual Objective Criteria

Individual Objective Criteria shall be taken into consideration on the appointment of Rapporteur/Co-Rapporteur and their assessment team(s). Individual assessors/experts should have specific and in depth scientific expertise and competence. Direct working experience in the relevant scientific area and regulatory experience are preferable (see Annex 1 of this Paper). The competence of the individual assessor/expert would address, as appropriate, aspects of the quality, safety, efficacy and pharmacovigilance, as applied to the medicinal products. Sufficient cross team complementary experience should be taken into consideration (as described above in Section 3.1 of this Paper).

3.3. In case of proposed assessment teams with similar objective criteria (scientific competence and availability), the following criterion will be used:

• Even distribution based on a statistical overview7, taken into account other procedures as well.

3.4. Choice between Rapporteur and Co-Rapporteur

• Ability to manage post-authorisation issues.

7 The appointment of Rapporteur/Co- Rapporteur and their assessment teams shall be accumulated through the 3-year CHMP “term” (nomination cycle).

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4. Methodology on the appointment of Rapporteur/Co- Rapporteur and their assessment teams A two-phase approach on the appointment of CHMP/CAT Rapporteur/Co-Rapporteur and their assessment teams is presented below: 4.1. First Phase This is a preparatory phase that will act as an indicator for the subsequent appointment of Rapporteur/Co-Rapporteur and their assessment teams. Its scope is to act as a pre-awareness step of forthcoming applications in the centralised regulatory system and will not necessarily prejudge the appointment of Rapporteur/Co-Rapporteur and their assessment teams (which will be appointed at the Second Phase). The interest, scientific competence and resources of expertise indicated by the EEA NCAs, CHMP Members (response per Member State delegation) at this phase will be distributed to the EEA NCAs/CHMP Members in order to ensure transparency of the indicated interests at EU level. For ATMPs, the above will also be distributed to CAT Members. A step-wise overview of the First Phase is outlined below:

Step 0

Task description Responsibility

Indication of interest When: Once a year (June of each year8)

P-R sends by email to EEA NCAs/CHMP Members: For ATMPs, the email will also be sent to CAT Members.

• Planning estimates of forthcoming applications and their therapeutic/technological areas.

P-R

EEA NCAs/ CHMP and CAT Members indication of interest/ scientific competence and resources Within 4 weeks

EEA NCAs/CHMP and CAT (only for ATMPs) Members will be requested within 4 weeks to:

• Indicate in writing within 4 weeks their interest and scientific competence and resources on these future applications.

EEA NCAs/ CHMP and CAT

Members

8 In June of each year, the EMA will send a draft estimate of the forthcoming applications expected in approximately the coming 18 months.

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Outcome of indication of interest/ scientific competence and resources

P-R compiles and circulates by email to EEA NCAs/ CHMP Members:

• The information received by EEA NCAs/CHMP Members on the requested indication of interest, scientific competence and resources.

• An overall tabulation reflecting future applications/timing of their proposed submission/indicated interest etc.

• Identification of difficulties in the allocation of scientific expertise (capacity/competence) in particular (new) therapeutic/technological area(s). In this case, the CHMP Secretariat will flag the issue at the next CHMP meeting in order to facilitate resolution in the allocation of scientific expertise.

The above includes CAT Members for ATMPs

P-R

4.2. Second Phase Normally, the appointment procedure for Rapporteur/Co-Rapporteur and their assessment teams will be initiated 7 months prior to the MAA submission intended date, to allow the actual Rapporteur/Co-Rapporteur appointment 6 months prior to the MAA intended submission date.9 The following steps shall be followed for the appointment of Rapporteur/Co- Rapporteur and their assessment teams:

Steps

Task description Responsibility

Step 1: Invitation to indicate interest Email and Circulation on Friday of the previous CHMP meeting

The CHMP Secretariat sends by email to all CHMP Members:

• An overview of all applications for which Rapporteurship is requested for nomination at the next CHMP meeting.

• A Nomination Form for Rapporteurship/Co-Rapporteurship.

The Committee Members (including alternates and co-opted Members) are invited to complete the received Nomination Form within approx. 2 weeks. For ATMPs, the email will also be sent to CAT Members. CAT Members need to complete the received Nomination form as described above.

CHMP Secretariat

Step 2: Nomination process Deadline: approx. 2 weeks before the next CHMP meeting

The CHMP Members will be requested to:

• Indicate in writing interest (in priority order) for Rapporteur/Co- Rapporteur per MAA.

• Indicate nominations for her/his assessment team with specific competence required for the particular MAA (as outlined in the Nomination Form).

The CHMP Members should submit electronically the completed Nomination Form(s) to CHMP Secretariat. For ATMPs, CAT Members are involved in the process as described

CHMP Members and CAT Members (if applicable)

9 In the case of re-examination of an opinion or of a referral procedure, appropriate timeframes shall be considered (please refer to the relevant Section 5 of this Paper).

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above for CHMP Members. Step 3: Appointment process

The CHMP Secretariat compiles the nominations received. If no nominations for Rapporteur/Co-Rapporteur are received for (a) certain MAA(s), go to step 3.1 Once the nomination process deadline (i.e. approx. 2 weeks before the next CHMP meeting) has expired, go to step 3.2

CHMP Secretariat

Step 3.1 If no nominations have been received:

• The CHMP Secretariat will send a reminder to CHMP and CAT (only for ATMPs) Member(s).

CHMP Secretariat

Step 3.2

If the nominations have been received:

• The CHMP Secretariat compiles all received nominations.

• The nominations will be circulated to the CHMP Chairman, CAT Chairman (if applicable) and to the Committee(s) Members approximately one week before the CHMP meeting, at which the Rapporteur/Co-Rapporteur and two CHMP Co-ordinators (only for ATMPs) will be appointed.

CHMP Secretariat

Step 4: Final appointment CHMP meeting

The CHMP Chairman will decide on the final Rapporteur/Co-Rapporteur and their assessment team appointment and will propose it to CHMP. For ATMPs, the CHMP Chairman and the CAT Chairman will decide on the final Rapporteur/Co-Rapporteur and their assessment team and two CHMP Coordinators appointment and will propose it to the CHMP. The final appointment by the CHMP is based on the Chairman(s)’s assessment of the nominations received taken into consideration the objective criteria described in Section 3 of this Paper.

CHMP Chairman

(CAT Chairman)

Step 5: Final appointment 1 week after the CHMP meeting

The final appointment of the Rapporteur/Co-Rapporteur shall be reflected in the CHMP Table of Decisions and circulated via the CHMP post-mail pack. For ATMPs, the final appointment of the CAT Rapporteur/Co-Rapporteur and CHMP Co-ordinators shall be circulated to all CAT and CHMP Members and reflected in the CAT Table of Decisions (ToD).

CHMP Secretariat

CAT Secretariat

Step 6: 1 week after the CHMP meeting

The applicant(s) are informed in writing by the CHMP Secretariat on the final appointment of the Rapporteur/Co-Rapporteur and their assessment teams the week after the CHMP meeting.

CHMP Secretariat

(copy to PTL and

Rapporteurs)

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4.3. Changes affecting the appointment of Rapporteur/Co-Rapporteur Further issues might be encountered and affect the appointment of Rapporteur/ Co- Rapporteur and their assessment teams: Related applications

Applicant informs the EMA on a revised intended MAA submission date.

• Applicant informs the appointed Rapporteur/Co-Rapporteur and CHMP Secretariat in writing and the issue is put in the Agenda of the next CHMP meeting for discussion.

• If appointed Rapporteur and/or Co-Rapporteur and their assessment teams are no longer available, a new appointment procedure shall take place (go to Step 1). Otherwise, the availability of appointed Rapporteur/Co-Rapporteur and their assessment teams will remain as is.

• For ATMPs, the CHMP Co-ordinators are part of the above process.

A previously withdrawn MAA is re-submitted:

• Normal appointment procedure of Rapporteur/Co-Rapporteur and their assessment teams shall take place (go to Step 1). Note: There is no automatic link to the previously appointed Rapporteur/Co-Rapporteur and their assessment teams for such MAA.

Availability of Rapporteur/Co-Rapporteur/member(s) of their assessment team

(A) member(s) of the assessment team if no longer available for the assessment (due to personal reasons, etc):

• The Rapporteur/Co-Rapporteur takes responsibility in replacing (a) member(s) with

similar competence and highlights to the CHMP Chairman / Committee if difficulties are foreseen in the replacement of the member(s) of their assessment team. Every effort should be made that no impact on the regulatory procedure is experienced (for instance delays in the delivery of the assessment report(s)). In the case of identified difficulties, a resolution is proposed. The CHMP Chairman / Committee is informed accordingly.

• For ATMPs, the CAT Chairman is also involved in the above process.

Rapporteur informs the Committee, at any time, that she/he is no longer available for the assessment (due to personal reasons etc): • Pre-authorisation phase:

Normally, the Rapporteurship will be taken over by the successor CHMP/CAT Member or alternate to work with the previously identified assessment team. The Committee shall confirm this appointment. If this is not feasible, then the appointment procedure of Rapporteur and her/his assessment team shall take place (go to Step 1).

• Post-authorisation phase:

Normally, the Rapporteurship will be taken over by the successor CHMP/CAT Member or alternate to work with the previously identified assessment team or if needed with a revised/new assessment team. If this is not feasible, then the appointment procedure of Rapporteur and her/his assessment team shall take place (go to Step 1). It would be expected that the newly appointed Rapporteur and her/his previously identified assessment team or her/his revised/new assessment team have specific Pharmacovigilance/Risk Management expertise.

Co-Rapporteur informs the Committee, at any time, that she/he is no longer available for the assessment (due to personal reasons, etc):

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• Pre-authorisation phase: Normally, the Co-Rapporteurship will be taken over by the successor CHMP/CAT Member or alternate to work with the previously identified assessment team. If this is not feasible, then the appointment procedure of Co-Rapporteur and her/his assessment teams shall take place (go to Step 1).

• Post-authorisation phase:

The Rapporteur and her/his assessment team shall lead the assessment (as is the normal practice). If the Co-Rapporteur’s input is required for a procedure, then normally the Co-Rapporteurship will be taken over by the successor CHMP /CAT Member or alternate to work with the previously identified assessment team or if needed with a revised/new assessment team. If this is not feasible, then the appointment procedure of Co-Rapporteur and her/his assessment teams shall take place (go to Step 1).

Co-opted CHMP Member informs the Committee, at any time, that she/he is no

longer available as Rapporteur/Co-Rapporteur for the assessment (due to personal reasons, etc):

• Co-opted CHMP Member affiliated to an EEA NCA.

The EEA NCA to identify a CHMP Member/alternate to take over the responsibility for (Co) Rapporteurship and to work with the previously identified assessment team. The Committee shall confirm this appointment.

• Co-opted CHMP Member not affiliated to an EEA NCA. The appointment procedure of Rapporteur/Co-Rapporteur and her/his assessment teams shall take place (go to Step 1).

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5. Appointment of Rapporteur/ Co- Rapporteur for other procedures 5.1. Re-examination of a CHMP opinion 5.1.1. Legal Framework

Re-examination of a CHMP opinion of a centralised application

Article 62(1) (fourth sub-paragraph) of Regulation (EC) No 726/2004 of the European

Parliament and of the Council states: “….If there is a request for re-examination of one of its opinions, the Committee concerned shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the initial opinion. The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee adopted the initial opinion. The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination.”

In addition, Article 11 of the CHMP Rules of Procedure (EMEA/CHMP/111481/2004) states: “For the implementation of the procedures for the re-examination of opinions mentioned in Article 9(2) of Regulation (EC) No 726/2004, in Article 32(4) of Directive 2001/83/EC, as amended, a different rapporteur and where previously appointed, a different co-rapporteur from those appointed for the initial evaluation, will be appointed to assess the grounds for the re-examination of opinions. This re-examination shall be made by using the best endeavours to ensure a new examination, independent from the first opinion”.

In addition, Article 10 of the CAT Rules of Procedure (EMEA/CAT/454446/2008) states: “For the implementation of the procedures for the re-examination of CHMP opinions as mentioned in Article 8(1) of Regulation (EC) No 1394/2007, different CAT (Co)-Rapporteurs from the one appointed for the initial CAT/CHMP evaluation are appointed to assess the grounds for the re-examination of opinions. This re-examination procedure shall use the best endeavour to ensure a new examination, independent from the first CHMP opinion.” Re-examination of a referral CHMP opinion

Article 32.4(d) of Directive 2001/83/EC, as amended refers to the fourth sub-paragraph of Article 62(1) of Regulation (EC) No 726/2004 of 31 March 2004.

5.1.2. Principles for the appointment of Rapporteur/Co-Rapporteur for re-examination of a CHMP opinion

• Normally, a Rapporteur and a Co-Rapporteur shall be appointed. o For CHMP opinions where the Co-Rapporteur was not involved in the

evaluation, no Co-Rapporteur for the re-examination of the CHMP opinion shall be appointed.

• A different Rapporteur and, where applicable, a different Co-Rapporteur from those appointed for the initial evaluation shall be appointed in order to assess the grounds for the re-examination of the CHMP opinion. These Rapporteurs will coordinate the evaluation for the duration of the re-examination procedure only.

• The principles outlined in section 2 of this Paper shall apply.

• The objective criteria as discussed in the relevant sections of this Paper shall apply.

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5.1.3. Methodology on the appointment of Rapporteur/Co-Rapporteur for re-examination of a CHMP opinion

• The Rapporteur, Co-Rapporteur (if applicable) appointment process will be initiated as soon as the EMA/CHMP receives written notice that the applicant/MAH wishes to request a re-examination of the CHMP opinion.

Strict timeframes shall be followed as there is no clock stop in the re-examination procedure (please refer to the CHMP Guideline on re-examination CHMP/50745/2005).

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5.2. Referrals 5.2.1. Legal Framework

• Articles 6(12) and 6(13) Commission Regulation (EC) No 1084/2003 • Article 29 of Directive 2001/83/EC, as amended (“Mutual Recognition and decentralised

referral”) • Article 30 of Directive 2001/83/EC, as amended (“Divergent Decision referral”) • Article 31 of Directive 2001/83/EC, as amended (“Community interest referral”) • Article 36 of Directive 2001/8/EC, as amended (“Follow-up referral”) • Procedure under Article 107(2) of Directive 2001/83/EC, as amended (“Pharmacovigilance

Urgent Measures”) • NTA, Volume 2A, Chapter 3

5.2.2. Principles to be considered for the appointment of CHMP Rapporteur/ Co-Rapporteur for referral procedures The principles outlined in Section 2 of this Paper shall apply. However, due to the particularities of the referral procedures [e.g. disagreement between the Member States (where applicable), lack of pre-submission phase, non predictability of the triggered referrals (with regards to the initiation of the referral), etc], with consequences on the workload and availability of CHMP Members, the following main principles shall be considered for the appointment of CHMP Rapporteur/Co-Rapporteur:

• Normally, for the scientific evaluation in respect of a referral procedure a Rapporteur and a Co-Rapporteur shall be appointed.

o In the case of class referrals, a lead Rapporteur and more than one Co-Rapporteur shall be appointed.

• The CHMP Chairman will decide on the final appointment of Rapporteur/Co-Rapporteur and will

propose it to the Committee.

• If no CHMP Member(s) volunteer(s) in the Rapporteur/Co-Rapporteur nomination procedure, the CHMP Chairman will designate the Rapporteur/Co-Rapporteur.

• The Applicant's proposals/preferences will not be considered for the appointment of

Rapporteur/Co-Rapporteur. The following shall be considered for the appointment of CHMP Rapporteur/Co-Rapporteur as per the particular referral procedure:

Article 29 of Directive 2001/83/EC, as amended, and Article 6(12) of Commission

Regulation (EC) No 1084/2003

In these Mutual Recognition and decentralised referrals no agreement has been reached between the Member States.

• Normally, the Rapporteur shall be a CHMP Member from the Reference Member State and the Co-Rapporteur shall be a CHMP Member from a concerned (divergent) Member State, in order to take advantage and benefit from their sound knowledge on the application and the referred issue(s).

Article 30 of Directive 2001/83/EC, as amended

In this referral, divergent decisions have been taken by the Member States related to the particular medicinal product.

• Normally, the Rapporteur shall be a CHMP Member from the triggering Member State and the Co-Rapporteurship shall be open to all CHMP Members (since the same competence and expertise would be expected on the referred issue(s)).

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• In the case that the European Commission or the MAH triggers the referral, normally the Rapporteurship/Co-Rapporteurship shall be open to all CHMP Members (since the same competence and expertise would be expected on the referred issue(s)).

Articles 31, 36 and 107(2) of Directive 2001/83/EC, as amended

In these referrals, interests of the Community public health (related to the medicinal product(s)) are involved.

• Normally, the Rapporteurship and Co-Rapporteurship shall be open to all CHMP Members, in order to ensure that the best and available expertise is appointed in these safety/Pharmacovigilance/ public health related referrals.

• In the case of class referrals, a lead Rapporteur and more than one

Co-Rapporteurs shall be appointed. The role of the lead Rapporteur in this case would primarily be to prepare a Joint Assessment Report considering all the comments raised by the team of the Co-Rapporteurs. In addition, the principles of the role of Rapporteur/Co-Rapporteur as outlined in Section 2 of this Paper shall apply.

• In the case that an Article 31 referral runs in parallel to Article 20 of Regulation (EC) No

726/2004 (where the substance concerned by the referral is also contained in centrally authorised medicinal products): Normally, either the Rapporteur or the Co-Rapporteur of the Article 20 procedure and Article 31 referral shall be the Rapporteur/Co-Rapporteur for the centrally authorised medicinal product, in order to take advantage and benefit from her/his sound knowledge of the application and to ensure consistency in the evaluation.

Article 6(13) of Commission Regulation (EC) No 1084/2003

In this referral the National Competent Authorities concerned by the medicinal product application are of the opinion that the variation cannot be accepted and the MAH may trigger a referral.

• Normally, the Rapporteurship and Co-Rapporteurship shall be open to all CHMP Members.

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5.2.4. Methodology on the appointment of Rapporteur/Co- Rapporteur for referral procedures Normally, the Rapporteur/Co-Rapporteur appointment process will be initiated as soon as the EMA/CHMP receives the referral notification. In case that the referral notification is received during a CHMP meeting and depending on the urgency of the matter (e.g. notification of safety issue(s)), the Rapporteur/Co-Rapporteur process shall take place during such meeting and be finalised optimally during that CHMP meeting. 5.2.5. Re-examination of a Referral CHMP opinion Legal Framework:

• Article 32.4(d) of Directive 2001/83/EC, as amended. • Article 62(1) of Regulation (EC) No 726/2004 (fourth sub-paragraph).

The principles and the methodology on the re-examination of a CHMP opinion as outlined in Section 5.1 of this Paper shall apply.

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5.3. Generics/Hybrids and Similar biological medicinal products 5.3.1. Legal Framework

• Article 10.1 of Directive 2001/83/EC, as amended (so called “generic application”) • Article 10.3 of Directive 2001/83/EC, as amended (so called “hybrid applications”) • NTA, Volume 2A, Chapter 1

5.3.2. Principles to be considered on the appointment of CHMP Rapporteur/ Co-Rapporteur and their assessment teams for Generic/hybrid medicinal products The principles outlined in Section 2 of this Paper shall apply. However, due to the particularities of generic/hybrid applications (e.g. legal basis, data requirements), the following principles shall be considered on the appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams:

• Appointment of Rapporteurs:

o For the scientific evaluation of a generic/hybrid medicinal product a Rapporteur shall be appointed.

Rapporteurships shall be open to all CHMP delegations. The scope of these Rapporteurships shall relate to the pre-authorisation phase and the introduction of quality changes in the post-authorisation maintenance.

In the case that several different generic companies apply for

applications based on the same bioequivalence study, the same Rapporteur shall be appointed in order to ensure and facilitate consistency in the scientific evaluation/post authorisation maintenance of the medicinal products concerned. Optimally, these cases shall be identified at EMA pre-submission meetings with generic companies.

For the scientific evaluation of a hybrid medicinal the appointment of a Co-Rapporteur shall be considered on a case-by-case basis (depending on the particularity of the applied hybrid medicinal product).

o For pharmacovigilance surveillance activities of generic/hybrid medicinal products a

pharmacovigilance (PhV) Rapporteur shall be appointed. Pharmacovigilance surveillance activities refer for instance to the evaluation of the PSURs, ADRs etc. (see also “Conduct of Pharmacovigilance for Centrally Authorised Medicinal Products” (CPMP/183/97).

The PhV Rapporteur shall be the same as previously appointed for the

reference medicinal product (please see below).

Normally, the same PhV Rapporteur shall be appointed for the same active substance(s) in order to enable/facilitate consistency in the pharmacovigilance monitoring/processing and follow-up of the medicinal product(s) concerned.

• The EMA Secretariat shall handle and finalise all other post-authorisation activities (i.e.

“administrative” harmonisation between the reference and the generic/hybrid medicinal product). These post-authorisation activities refer to the implementation of product information (SPC/labelling/PL) changes of the generic/hybrid medicinal product following changes of the reference medicinal product. These changes might be following safety variation(s)/urgent safety restriction(s) of the reference medicinal product. This approach is by analogy to the Type IA variation approach in the centralised procedure.

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For non- centrally authorised reference medicinal product (s), a mechanism shall be established to ensure awareness of such product information changes (for instance through feedback from the CMD(h)).

• The Applicant's proposals/preferences will not be considered for the appointment of Rapporteur/Co-Rapporteur. Reference medicinal product Depending on the regulatory route of authorisation of the reference medicinal product the following may normally apply (where relevant) for the appointment of the PhV Rapporteur:

Reference medicinal product is a centrally authorised medicinal

product:

• The PhV Rapporteur shall be the same as the previously appointed Rapporteur for the reference medicinal product.

Reference medicinal product is authorised through a Mutual

Recognition/ Decentralised procedure(MRP/DCP):

• Normally, where available, the PhV Rapporteur shall be a CHMP Member representing the Reference Member State (RMS) where the reference medicinal product has been authorised.

o In the case that there are several Reference Member States for

the same concerned reference medicinal product, CHMP Members represented by these Member States shall try to reach an agreement between themselves on who will take the Rapporteurship, respecting any prior discussion/agreement within the CMD(h).

Reference medicinal product is authorised through a National

procedure:

• Normally, where available, the PhV Rapporteur shall be a CHMP Member representing an EEA National Authority where the reference medicinal product has been authorised, respecting any prior discussion/agreement within the CMD(h).

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5.3.3. Methodology on the appointment of Rapporteur/Co- Rapporteur and their assessment teams for Generic/Hybrid medicinal products Normally, for generic applications the appointment procedure of the Rapporteur and her/his assessment team will be initiated at a CHMP meeting preferably 3-7 months prior to the MAA submission date, to allow the actual Rapporteur /Co-Rapporteur appointment 2-6 months prior to the MAA intended submission date. At the same time the PhV Rapporteur will be identified. Normally, for hybrid applications the appointment procedure of Rapporteur/Co-Rapporteur and her/his assessment teams will be initiated as early as 7 months prior to the MAA submission date, to allow Rapporteur /Co-Rapporteur appointment 6 months prior to the MAA intended submission date. At the same time the PhV Rapporteur will be identified. The methodological steps for the appointment procedure of Rapporteur/Co-Rapporteur (where relevant) and their assessment team as outlined in Section 4.2 of this Paper shall apply. 5.3.4. Re-examination of a CHMP opinion of a Generic/hybrid medicinal product 5.3.4.1. Legal Framework

• Article 62(1) of Regulation (EC) No 726/2004 of 31 March 2004 (fourth subparagraph).

The principles and the methodology on the re-examination of a CHMP opinion as outlined in Section 5.1 of this Paper shall apply.

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5.4. Similar biological medicinal products 5.4.1. Legal Framework

• Article 10.4 of Directive 2001/83/EC, as amended • Annex I to Directive 2001/83/EC, Part II, Section 4 • NTA, Volume 2A, Chapter 1

5.4.2. Principles and Objective Criteria to be considered on the appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams for similar biological medicinal products The principles outlined in Section 2 of this Paper shall apply. However, due to the particularities of the similar biological medicinal product applications (e.g. legal basis, data requirements), the following principles shall be considered on the appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams:

• Appointment of Rapporteur/Co-Rapporteur:

o For the scientific evaluation of a similar biological medicinal product a Rapporteur and a Co-Rapporteur shall be appointed.

In the pre-authorisation phase both the Rapporteur and

Co-Rapporteur shall be involved. The appointment process shall be open to all CHMP delegations.

For all quality changes in the post-authorisation phase and pharmacovigilance aspects the Rapporteur shall take the lead role.

• The EMA Secretariat shall handle and finalise all other post-authorisation activities (i.e.

“administrative” harmonisation between the reference (see below) and the similar biological medicinal product). These post-authorisation activities refer to the implementation of product information (SPC/labelling/PL) changes of the similar biological medicinal product following changes of the reference medicinal product (please see also section 5.3.2. on this issue). This approach is by analogy to the Type IA variation approach in the centralised procedure.

• The Applicant's proposals/preferences will not be considered for the appointment of the Rapporteur/Co-Rapporteur.

Reference medicinal product The reference medicinal product of a similar biological medicinal product could be a centrally authorised medicinal product, or authorised through an Ex-concertation/Mutual Recognition/ Decentralised procedure (MRP/DCP) or a national procedure. 5.4.3. Methodology on the appointment of Rapporteur/Co- Rapporteur and their assessment teams for similar biological medicinal products Normally, the appointment procedure for Rapporteur/Co-Rapporteur and their assessment teams will be initiated at a CHMP meeting preferably 7 months prior to the MAA submission date, to the actual allow Rapporteur /Co-Rapporteur appointment 6 months prior to the MAA intended submission date. The methodological steps for the appointment procedure of Rapporteur/Co-Rapporteur and their assessment teams as outlined in Section 4.2 of this Paper shall apply.

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5.4.4. Re-examination of a CHMP opinion of a similar biological medicinal product Legal Framework


The principles and the methodology on the re-examination of a CHMP opinion outlined in Section 5.1 of this Paper shall apply.

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5.5. Non-prescription medicinal products 5.5.1. Legal Framework

• Article 72 of Directive 2001/83/EC, as amended • Article 72a of Directive 2001/83/EC, as amended • Recital 9 and Article 3(2) of Regulation (EC) No 726/2004

5.5.2. Principles and Objective Criteria to be considered on the appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams for non-prescription medicinal products The principles outlined in Section 2 of this Paper shall apply. However, due to the particularities of non-prescription medicinal product applications (e.g. self-care environment, data requirements), the following principles shall be considered on the appointment of CHMP Rapporteur/Co-Rapporteur and their assessment teams:

• Appointment of Rapporteur/Co-Rapporteur:

o For the scientific evaluation of a non-prescription medicinal product a Rapporteur and a Co-Rapporteur shall be appointed.

In the pre-authorisation phase both the Rapporteur and

Co-Rapporteur shall be involved. The appointment process shall be open to all CHMP delegations however specific experience in non-prescription medicinal product assessments shall be sought. Additional experience with change in legal status from prescription to non-prescription will also be requested. Experience in communication with patients is also foreseen.

In the post-authorisation phase, when a change in legal status is foreseen (e.g. switch from prescription to non-prescription), a peer reviewer shall be appointed to work with the existing Rapporteur and Co-Rapporteur already in place for the given medicinal product. The suitable candidate for peer review should have relevant knowledge of the area of non-prescription medicinal products and if possible previous experience in changing the legal status of a medicine/active substance from prescription to non-prescription.

• The Applicant's proposals/preferences will not be considered for the appointment of the

Rapporteur/Co-Rapporteur. 5.5.3. Methodology on the appointment of Rapporteur/Co- Rapporteur and their assessment teams for non-prescription medicinal products Normally, the appointment procedure for Rapporteur/Co-Rapporteur and their assessment teams will be initiated at a CHMP meeting preferably 7 months prior to the MAA submission date, to allow Rapporteur /Co-Rapporteur appointment 6 months prior to the MAA intended submission date. In case of a change in legal status (prescription to non-prescription), the appointment of a peer reviewer will be initiated at a CHMP meeting prior to the intended submission date.

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5.5.4. Re-examination of a CHMP opinion of a non-prescription medicinal product Legal Framework


The principles and the methodology on the re-examination of a CHMP opinion outlined in Section 5.1 of this Paper shall apply. Rapporteur and Co-rapporteur appointed shall possess re-examination experience together with solid knowledge of non-prescription medicinal products assessment. Experience with legal status change of a medicine/active substance from prescription to non-prescription is also foreseen as well as experience in communication with patients.

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References

Regulation (EC) No 726/2004 of the European Parliament and of the Council, of 31 March 2004

Directive 2001/83/EC, as amended and its Annex I Notice To Applicants, Volume 2A CHMP Rules of Procedure (EMEA/CHMP/111481/2004, adopted by the CHMP in September

2004) CAT Rules of Procedure (EMEA/CAT/454446/2008) Procedural advice on evaluation of Advanced Therapy Medicinal Products (ATMPs)

(EMEA/630043/2008) EMA Road Map to 2010 EMA Pre-submission Guidance for users of the centralised procedure EMA Post authorisation Guidance –Human Medicinal Products (EMEA/H/19984/03) Check of Experts for meetings (SOP/H/3021, EMEA/201528/2004) Check of Expert for product evaluation (SOP/H/3022, EMEA/127437/2005) (procedure for

inclusion of experts in the Expert DataBase) EMA policy on the handling of conflict of Interests for EMA Scientific Committees Members

and Experts The EMA code of conduct Guideline on re-examination (CHMP/50745/2005) Guideline on Similar Biological Medicinal Products (CHMP/437/04) Peer Review/Quality assurance of the Day 120 CHMP List of Questions and assessment

reports (SOP/H/3015) Conduct of Pharmacovigilance for Centrally Authorised Medicinal Products (CPMP/183/97)

Abbreviations

• ATMPs Advanced Therapy Medicinal Products (ATMPs) • CAT Committee for Advanced Therapies • CHMP Committee for Medicinal Products for Human use • CMD(h) Co-ordination Group for Mutual Recognition and Decentralised

Procedures - Human • DCP Decentralised procedure • EEA European Economic Area • EU European Union • MAA Marketing Authorisation Application • MAH Marketing Authorization Holder • MRP Mutual Recognition Procedure • NCA National Competent Authority • PTL Product Team Leader • PTM Product Team Member • PhV PharmacoVigilance • PL Package Leaflet • QAS Quality Assurance System • RMS Reference Member State • SAGs Scientific Advisory Groups • SPC Summary of the Product Characteristics

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Annex 1

Individual Objective Criteria to be taken into consideration for the appointment of the Rapporteur/Co-Rapporteur and their assessment teams.

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Individual Objective Criteria The following Individual Objective Criteria should be considered for the appointment of the assessor(s)/expert(s):

• Academic expertise in the relevant scientific area, such as:

o Internationally recognised academic qualification(s) /accreditation(s) (e.g. Degrees, Diplomas, Post Graduate Qualifications (e.g. PhD), Professional Affiliations etc)

o Delivering scientific expert views/opinions to National/European/International scientific bodies

• Direct working experience in the relevant scientific area, such as:

o Clinical Co-ordinator/Investigator in clinical trials

o Clinical expertise (e.g. specialisation) in the relevant area

o Pre-clinical research and expertise (e.g. in toxicology, pharmacology)

o Scientific research (e.g. in epidemiological studies, animal studies etc)

o Research in the relevant “quality” areas, relating to the research and development of medicinal products (e.g. molecular biology, gene technology etc)

o Formulation, manufacture and control of medicinal products o Inspection (GXP inspection)

o Pharmacovigilance and Risk Management

o Targeted Publications in recognised and peer-reviewed scientific journals

o Peer Reviewing activities for scientific journals o Advisory experience in Committees’/scientific bodies’ activities (e.g. experience in

providing scientific advice for central and/or national MAs, involvement in WHO, EDQM, FDA activities etc)

o Previous involvement in EU Commission activities, such as receipt of grants within the Framework Programs leading for example to publication in well recognised scientific journals

o Regulatory experience such as writing Assessment Reports, participating in Scientific Advice etc

o Medical Device o Involvement in changing the legal status of a medicine from prescription to non-

prescription o Regulatory experience with assessment of non-prescription medicinal product;

experience in communication with patients

Procedural Advice on CHMP_CAT Rapporteur_co-rapporteur

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