BuildingBuilding a a regulatoryregulatory capacity capacity in a in a regulatoryregulatory networknetwork: : experienceexperience fromfromTwinningTwinning projectsprojects and EU and EU worksharingworksharing

Dagmar StaráState Institute for Drug Control, Bratislava

Slovak Republic

ICDRA, Bern 2008workshop „Building regulatory capacity: best practices for future“

BuildingBuilding a a regulatoryregulatory capacity capacity in a in a regulatoryregulatory networknetwork: : experienceexperience from from TwinningTwinning projectsprojects and EU and EU worksharingworksharing

• SIDC in the EU medicines regulatory network

• Addressing the capacity: EU worksharing

• Strenghtening the administration: Twinning projects

• Non-EU network experience: CADREAC

• Conclusions

SK in SK in thethe EU EU medicinesmedicines regulatoryregulatory networknetwork

Co-ordination Group for Mutual Recognitionand Decentralised Procedures - Human

Ministry of Health SK

CHMPCOMPHCMPPDCOCAT ~ State Institute

for Drug Control (SK)

European Parliament EU legal framework Council of the EU

SK Parliament SK legal framework SK Government

~ 30 DRAs

CommonCommon EU EU proceduresprocedures and and activitiesactivities basedbased in in legislationlegislation::

•• centralisedcentralised proceduresproceduresmedicinal products, orphan, paediatric, advanced therapies, herbals; CHMP referral

•• decentraliseddecentralised commoncommon proceduresproceduresmutual recognition and decentralised procedures,

CMDh referral based on potentially serious risk to public health

•• nationalnational proceduresprocedures (SK)(SK)harmonisation incl. product infomation/ shared information/ shared knowledge/ worksharing/

IT : IT : databasesdatabases and and communicationcommunication

SK in SK in thethe EU EU medicinesmedicines regulatoryregulatory networknetwork

WorksharingWorksharing based on Heads of Agencies agreements:

• PSURs, paediatric data, quality of medicines (pilot)

principle: base on the assessment report of the reference MS discussionand agreement of all concerned MSs on the final assessment report

saves resources, supports harmonisation, mutual confidence by working together

BenefitBenefit for a medium size regulatory agency – resources focused on priorities:risk analysis, national responsibilities, specific resources and knowledgerapporteurship to develop assessment know-how and excellence

•• ChallengeChallenge – contribution to the network (demanding on resources)

BenchmarkingBenchmarking

SK in SK in thethe EU EU medicinesmedicines regulatoryregulatory networknetwork

EU EU MemberMember State´sState´s DRA: DRA: SIDCSIDC

• 5 million inhabitants

• ~ 5 000 medicinal products approved

• national decisions (MRP/DCP ~ 40%) and EU decisions ~10%

• 200 staff membres (pharmaceuticals and medical devices, MA, inspections, clinical trials, advertisement)

• In- house quality and external pre-clinical and clinical assessors

• Priorities in the EU network: SK=RMS procedures

• Assessment priorities (generics, RMS DCP/MRP, CMDh referrals)

• Product information in the Slovak Language

• Inspections within EU network

5 550

3568

15

1190

335450

39347 15149

190791

55 8168

560

2554

814

4

1682

540

1 000

2 000

3 000

4 000

5 000

6 000

all products national decisions2008

nationalapplications 2008

national variations

all procedures national RMS MRP DCP EU

RMSnational only

Type Type ofof thethe procedureprocedure: : decisionsdecisions and and applicationsapplications

• 1999 MATRA-IMPACT (NL) internship (SK)

• 2000-2004 Pan European Regulatory Forum, PERF (Phare) – future 25 MSs• 2000 conference MEB (NL) -SIDC (SK)

• 2004 PUM/ NMCP (NL) progamme in SIDC (SK) – workshops incl.

• 2007 twinning light (Phare) MEB, RIVM (NL) – SIDC (SK) – workshops incl.

• implementation of the EU acquis communautaire

• institution building: training for coordinators, assessors, management, lawyers

• building a mutual confidence, an opportunity to learn from each other

Strenghtening the administration: Twinning projects

SIDC phasing in the EU network

Strengthening the administrative capacity of the SIDCas regards medicinal products for human use

• project fiche developed based on previous experience

• EU accession from 1st May 2004, new legal framework

EU medicines regulatory network benefits

how shall we contribute ?

• learn from one of the best, continuity in relation and training

TWL 2007 TWL 2007 project project IdeasIdeas

17 NL experts ~ 50 SIDC internal staff trained (coordinators assessors, lawyers, IT)~ 8 SIDC management ~ 27 SIDC external assessors trained

• „reference member state“ role:- Assessment Report QSE and Product information (User testing), coordination of the EU procedure and responsibility for the medicinal product during the whole life-cycle

• strengthening the administrative capacity – management (how to do things better ? )

• working with stakeholders – patient in the centre

• target training groups: coordinators, assessors (QSE), management, lawyers, QM

• cross attendance (multidiscuplinary team approach: coordinators, inspectors GCP/ GMP, PhV staff, lawyers)

TWL 2007 TWL 2007 projectproject GoalsGoals and and expectationsexpectations

• learning (scientific assessment, negotiation, team work)

• EU spirit, creating EU environment „at home“

• building mutual confidence

• enjoy working together

training methods: lectures, seminars and• training by doing, workshops, case studies, role playing,

flexibility: ad hoc facilitation meeting

• writing an Assessment report – quality, safety, efficacy

• confidentiality: dossiers taken from common procedures

TWL 2007 TWL 2007 projectproject WorkingWorking methodsmethods

• 2 RMS MRP procedures followed by 1 DCP recently

• new BE/BA (PK) assessors group established (is still active)

• new knowledge gained, existing one transformed to a new quality

• professional self-confidence of staff members developed

• management topics: (re-)organisation (practical cases and approaches discussed), resources, staff motivation,transparency, quality management

• specific issues: e-submission, risk management• established experts network proven by practice in the process of

finalisation of ARs outside the regular TWL meetings

TWL 2007 TWL 2007 projectproject ResultsResults

bilateral/ multilareal/ EU network twinning beneficial

☺ clearly formulated target of the project streamlined

the organisation and work

a satisfaction when tergets reached in the end

less complicated structure of a future project

particularly if the project approval takes months-years

SIDC staff now trained: need to continue with internal resources

both for new and experienced staff (different focus)

LessonsLessons learnedlearned FutureFuture activitiesactivities

NonNon--EUEU networknetwork experienceexperience: : CADREACCADREAC

• 10 EU candidate countries till 2004

• cooperation

• support in alignment with EU acquis communautaire

• 2 common procedures: simplified marketing authorisation of EU centrally approved/ mutually recognized products

• learning

New CADREAC

ConclusionsConclusions

• Benefit from regional networks

• Bilateral/ multirateral projects:

- building mutual trust (condition for worksharing)

- training by doing together, strengthening self-confidence

- international work experience and social skills

- partnerships

• Small DRAs can profit from infomation publicly available:

EPARs, PARs, WHO prequalification programme

• Worksharing without legal bounds ?

Bratislava, Slovak RepublicDanubiana museum