How to Participate in the Elaboration and Revision of Monographs · THE EUROPEAN DIRECTORATE FOR...

THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM)

2 ©2020 EDQM, Council of Europe. All rights reserved.

How to Participate in the Elaboration and Revision of

MonographsIsabelle Mercier

European Pharmacopoeia Department EDQM, Council of Europe


Basis for Monographs

Monographs should take account of all currently approved products

Approved specifications are the main basis backed up by batch data and stability data

Draft monographs are checked by users and regulatoryauthorities at Pharmeuropa stage

Policy for monograph elaboration is given in:Technical Guide for the Elaboration of Monographs(available on the EDQM website)

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Elaboration or Revision of a text

Request for elaboration/ revision

Approval by the

Commission

Allocation to a WorkingProcedure

Assignment to a Group of

expertsElaboration / revision of the

text by the Group

Public enquiry in

Pharmeuropa

Text adoptedby the

Commission

Publication

Delegation of a Member StateExperts, EDQM ProducersChair of the Ph. Eur. Commission

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Proposing a new monograph

Contact the EDQM [in Europe: National Pharmacopoeia Authority]

Initial data: countries (in Europe) where the product is approved Data package:

• Current specification• Analytical procedures (SOPs)• Corresponding validation reports • Batch and stability data• Justification for spec., list of potential impurities, [pharmaceutical

development data]• Samples of the [medicinal product], substance and impurities

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Developments in Regulatory

Environmente.g. Guidelines, ICH Q3D-

elemental impuritiesICH Q8/Q9/Q10/Q11,

REACH

Scientific / technical evolutions

e.g. Fast LC, PAT, new molecules, new

therapies Developments in Manufacture and

Globalisatione.g. Continuous

manufacturing, new routes of synthesis

New risks to Public Health

e.g. Genotoxic impurities, TSE, contamination/

falsification (heparins)

Increased demand for Generic and

Biosimilar productse.g. New sources

Need to regularlyreview and update

Ph. Eur. texts _ need to create

new texts

Revision: Why?

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Revision Programme

Work programme is announced via EDQM website and directly to industry associations and pharmacopoeia liaison contacts(http://www.edqm.eu/en/european-pharmacopoeia-work-programme-607.html)

Stakeholders to: • Declare an interest for relevant items• Consider Pharmeuropa for new and revision proposals• Experimentally check draft proposals • Send comments on draft proposals• Provide samples upon request

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How to Request a Revision?• Go the EDQM website: https://www.edqm.eu/en/submitting-drafts-and-requests-revision


Request for Revision of a Ph. Eur. Text


Request for Revision

Revision can only be undertaken if the request is backed up by sufficient data

Provide batch data, chromatograms, etc. to enable a decision on the need for revision

Supply validated methods (if possible, cross-validatedagainst official Ph. Eur. method) and samples notably for all impurities controlled by the new method

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Make clear what needs revising and, if possible, make a concrete proposal

Make clear what needs revising and, if possible, make a concrete proposal


And then?

Outside Ph. Eur. Member states: contact EDQM which will refer the matter to a group of experts or to the Ph. Eur. Commission first

Ph. Eur. Member States: via National Pharmacopoeia Authority (address list on EDQM website and in

Pharmeuropa online)


Elaboration or Revision of a Text

Request for elaboration /

revisionApproval by

the Commission

Allocation to a

WorkingProcedure



text by the Group

Public enquiry in

Pharmeuropa

Text adoptedby the

Commission

Publication

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How are Texts Elaborated / Revised?

Procedure 1 (Group of experts): Multi-source products and monograph revisionsOn request, data are handled confidentially by EDQM

Procedure 4 (Group of regulators/OMCLs): Single-source products, direct co-operation with innovator Data are handled confidentially by EDQM


How are Texts Elaborated / Revised?

MONOGRAPH

PRO

CED

URE

1 (P

1)

Revision

PROCED

URE 4 (P4)To be applicable to B, C, D ….

Revision (P1)

MONOGRAPH valid for A, B, C & D

AB C

D A

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P4 Procedure: Aim

Elaborate monographs for single-sourcesubstances/medicinal products (still under patent) with a potential for further generics

Based on authorised products Monograph ready > 2 years before patent expiry (ideally) Possibility of starting elaboration work 5 years after first MA

approval Protection of proprietary information: expert group P4 solely

composed of regulators, OMCLs and EDQM Secretariat

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revisionApproval by

the Commission


Assignmentto a Group of expertsElaboration /

revision of the text by the

Group

Public enquiry in

Pharmeuropa

Text adoptedby the

Commission

Publication

C. Vielle ©2018 EDQM, Council of Europe. All rights reserved. 16



Appointment - By Whom? Groups of experts and working parties – appointed by the

Ph. Eur. Commission 800 experts in pharmaceutical sciences from the Ph. Eur.

Members States, observers and third countries The Ph. Eur. Commission has revised its working procedures to

open up to the nomination of experts from non-Ph. Eur. member states and non-observer states

EDQM web site: https://www.edqm.eu/en/join-network

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Example:




revisionApproval by

the Commission



expertsElaboration / revision of the text by the Group

Public enquiry in

Pharmeuropa

Text adoptedby the

Commission

Publication

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How to Comment?!




revisionApproval by

the Commission




text by the Group

Public enquiry in

Pharmeuropa

Textadopted by

the Commission

Publication

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Adoption of the Text (New or Revised)

Submission to Ph. Eur. Commission for adoption

Publication in the Ph. Eur. Implementation 1 year after adoption

(see publication schedule available on website)

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Overall timescale: minimum 2 years

Including 5 months for public enquiry and at least 6 months between adoption and publication


After Revision: Why ? FAQ: “Why did you revise the chapter/monograph on …?”

The answer can be found out via: Notes on the chapter/monograph in Pharmeuropa texts Compiled notes posted on Pharmeuropa online / Useful

information for each new edition/supplement (Comments concerning revised texts…) https://pharmeuropa.edqm.eu/home

Knowledge database (history)

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Usually no notes for corrections


0 The monograph has beenauthorised but work has notstarted yet1 Work has started (first draft)2 The monograph has beenauthorised for publication inPharmeuropa (see Pharmeuropanumber)3 The monograph has been submittedfor adoption to the EuropeanPharmacopoeia Commission4 The monograph has been adopted5 The monograph is about to bepublished, or has been published (seethe supplement number indicated andthe calendar of the editions below)

The number of the last issue ofPharmeuropa into which a draft of themonograph was published

The section reflects the status of the text with regard to the work of: • the Pharmacopoeia Discussion Group

(PDG), a joint collaboration between the United States Pharmacopeia, the Japanese Pharmacopeia and the European Pharmacopoeia.

• the International Conference on Harmonisation (ICH) Quality Guideline on Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH (Q4B).

Further information can be found in chapter 5.8 (Pharmacopoeial Harmonisation) of the European Pharmacopoeia.

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Monographunderelaboration


On-going revision

- Aim of the revision - State of work- The number of the last issue of Pharmeuropa into which a draft of the monograph was published

For guidance purposes: provides additional nformationto users e.g. column tradenames

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If certificate(s) of suitabilityhave been granted for thesubstance in question, their listis shown. This is an excerptfrom the online List of CEP.

History: contains informationconcerning certain technicalmodifications to some revised/correctedtexts published since Ph. Eur. 5.0. Thisinformation complements themodifications indicated by lines in themargin in the supplements and is notnecessarily exhaustive.

Monographunderrevision


Agreement by the Ph. Eur.

Commission

Ph. Eur. Monograph Elaboration/Revision: to summarise

• Data package (current specifications, analytical procedures; validation data; batch and stability data)

• Material for testing• Candidate material for

RS establishment

Request for monograph elaboration/

revision 1 2

Call for interest

Elaborationor revision of the text by the Group

• Review of data package• Draft monograph

elaboration• Laboratory study/

collaborative testing

Participation of interested

parties

Participation of interested

parties

Responding to Pharmeuropa

enquiry is a must

• Draft published for comments (testing of draft monograph) – 3 months commenting period

• Evaluation of stakeholder feedback (technical comments, data)

3Assignment to a Group of Experts

4 5Public

enquiry Pharmeuropa

Text adopted by the Ph. Eur.

Commission 6

Publication in the

Ph. Eur.7

Once a monograph ispublished and implemented, MAH’sof registered productshave to assure theirproduct meets the requirements of the monograph

Monographs are based on quality described for approved products

Industry, OMCLs, assessors


Pharmacopoeia Liaison

EDQM wishes to have a pharmacopoeia liaison contact for each major manufacturer / user who would: Channel information and requests from manufacturer

to EDQM Be a reception point for contact by EDQM

Benefits for both sides

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Stay connected with the EDQM

©2019 EDQM, Council of Europe. All rights reserved.

Thank you for your attention

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