Cooperation between regulators in Africa experience from the EU system. Pretoria Dr Tomas Salmonson. Chair, CHMP, EMA, UK

Transcription

1 Cooperation between regulators in Africa experience from the EU system Pretoria 2015 Dr Tomas Salmonson Chair, CHMP, EMA, UK

2 Outline of presentation Introduction the European context European Medicines Agency since 1995 CHMP Review of an application Selection of Rapporteurs - BEMA Training of assessors?questions? 2

3 EU geographical incremental steps 2006 EUR EUR EUR 28 An agency of the European Union

4 EU network Public Patient organisations EU Commission Health care systems EMA 40 National Agencies Companies International organisations An agency of the European Union

5 "Downstream" stakeholders include: HTA bodies Payers National/regional/local drug committees Prescribers Patients 5

6 EU Marketing Authorisation Regulatory systems Post Nov 2005 Three European Systems - Still possible for authorisation in a single MS 6 The Centralised & Decentralised procedures allow: - Better Resource Utilisation / - Harmonised Scientific Opinions & Information to Doctors / Patients

7 Outline of presentation Introduction the European context European Medicines Agency since 1995 CHMP Review of an application Selection of Rapporteurs - BEMA Training of assessors?questions? 7

8 In the beginning... 8 Presentation title (to edit, click Insert > Header & Footer)

9 CHMP 95 CVMP COMP 00 HMPC 04 PDCO 07 CAT 09 PRAC 12

10 10

11 Outline of presentation Introduction the European context European Medicines Agency since 1995 CHMP Review of an application Selection of Rapporteurs - BEMA Training of assessors?questions? 11

12 Committee for Human Medicinal Products (CHMP) Chair and Vice Chair + 1 member + 1 alternate/ms + 5 co-opted members + Tomas Salmonson Chair CHMP accompanied by experts Pierre Demolis Vice-Chair CHMP co-opted members

13 CHMP Working Parties and Expert Groups (not all..) Patients & Consumers Organisations WP Safety WP Quality WP Biologics WP Ad hoc groups Infectious Diseases WP Scientific Advice WP CHMP Working Parties Biosimilars WP Scientific Advisory Groups (SAGs) Pharmacogenomics WP Blood Products WP Vaccine WP 13 13

14 Patients & Consumers Organisations WP Safety WP Quality WP Biologics WP Ad hoc groups Infectious Diseases WP Scientific Advice WP CHMP Working Parties Biosimilars WP Scientific Advisory Groups (SAGs) Pharmacogenomics WP Blood Products WP Vaccine WP 14 14

15 Working Parties and other Groups Others Biostatistics Pharmacokinetics Pharmacogenomics Biosimilar Blood products Geriatrics Rheum./Immuno. Gastroenterology ( ) Working Group on Quality Review of documents (QRD) CHMP / CVMP CVMP 15 As necessary SAG vaccines CAT BWP* COMP SAG diagnostics SAG HIV / Antiviral HCP WG PCWP CHMP Sci.Adv WP SAG CVS SAG Antiinfectives PRAC QWP* PDCO SWP* SAG Oncology SAG Neurology SAG Diabetes Endoc. SAG Psychiatry CMDh * 1 / MS representation SAG CVS GCP Inspectors Working Group

16 Outline of presentation Introduction the European context European Medicines Agency since 1995 CHMP Review of an application Selection of Rapporteurs - BEMA Training of assessors?questions? 16

17 Centralised procedure Single scientific opinion Max. 210 evaluation days to Opinion 1 marketing authorisation valid EU 1 (invented) name 1 common Product information Transparent system (e.g. EPAR) 23 languages +IS/NO 28 Member States Access to potentially 500 million users

18 Review of an application - important features Guidance and templates (eg. B/R section) Two independent assessment reports Peer-review comments (one member plus EMA) Comments from members (involvement of Working Parties such as QWP, BWP, PKWP, BSWP etc) Input from external experts and patients 18

19 Centralised Procedure Overview D -180 S T A R T App R/cR Assess Teams Rap Assessment Co-Rap D 80 Rap AR Co- Rap AR CHMP Comments D 115 Peer Revie w Teleco n Interaction with PRAC D 120 Joint LoQ Clock Stop (3 6 m) D 121 Response Submission SAG / WP consultation Secondary Evaluation Decision Making D 121 Response Submissio n D 150 Joint Response AR CHMP Comments D 180 LoOI D 181 Oral Expl D 210 Opinio n Inspections GMP / GCP Clock Stop (1-3 m) Consensus Simple Majority 19 Interaction with PRAC

20 Oral Explanation day recommendations Max 10 company representatives 1-2 people presenting, confident with data 20 min presentation Focus on key-issues Quality not quantity honest approach Know what the applicant is prepared to commit to (restricted indication / Post-Authorisation commitments etc ) Know if you will withdraw or go into negative opinion (+ re-examination)

21 CHMP Voting Rules 33 members eligible to vote (28 MS/NCAs + 5 co-opted) Norway and Iceland recorded separately Quorum = Abstention! Voting Simple Majority: 17 to sustain a positive or negative opinion No pre-determined MS position CHMP capacity scientific member, hence vote personal / individual

22 Outline of presentation Introduction the European context European Medicines Agency since 1995 CHMP Review of an application Selection of Rapporteurs - BEMA Training of assessors?questions? 22

23 Outline of presentation Introduction the European context European Medicines Agency since 1995 CHMP Review of an application Selection of Rapporteurs - BEMA Training of assessors?questions? 23

24 Benchmarking of European Medicines Agencies Steering Group (BEMA SG) Introduction/Overview/Mandate HMA (Joint Human and Veterinary) has established a benchmarking programme among the human and veterinary medicines agencies known as the Benchmarking of European Medicines Agencies (BEMA). The programme has the following broad aim: 1. To contribute to the development of a world-class medicines regulatory system based on a network of agencies operating to best practice standards. BEMA is based on assessment of the systems and processes in individual agencies against a set of indicators which have been agreed in the following areas: 2. Management systems; 3. Assessment of marketing authorisation applications; 4. Pharmacovigilance (drug safety) activities; and 5. Inspection services. The assessment is an opportunity to identify strengths and best practices in agencies and any opportunities for improvement; it is not an audit designed to identify non-compliance. The exercise is not designed for direct comparison or ranking of agencies. Agencies are encouraged to install suitable best practices in order to enable an improved operation of the network of agencies. 24

25 Outline of presentation Introduction the European context European Medicines Agency since 1995 CHMP Review of an application Selection of Rapporteurs - BEMA Training of assessors?questions? 25

26 EU Network Training Centre online platform Communication tool Training Catalogue Launch 30 January 2015 at Eudraportal for the EU Network! Use your ECD credentials! 26

27 NCAs and EMA training offers for 2015 The EU NTC received: About 35 training offers from 19 NCAs. About 20 training offers from EMA. This training offers cover the Human and Vet areas. 27

28 EU NTC provides the first online joint calendar Over 80 training events are offered! 28

29 Content specific training of assessors and inspectors - examples 29

30 EMA EU Network Training & Regulatory Capacity initiatives Translating guidance documents to practice - EMA organises specific workshops or awareness session on new guidelines - Case studies describing the challenge and how to deal with it Examples of published videos on guidance documents Assessors training Guideline on Investigation of Drug Interaction Assessors' webinar on the PSUR assessment procedure Awareness session on Non-clinical evaluation of medicinal products Blood Products Assessors' Training BPWP Assessors' training on immunoglobulins and potential thromboembolic events 30

31 EMA EU Network Training & Regulatory Capacity initiatives GMP Inspection related Training activities Cooperation agreement with EMA / PIC/S with specific focus on training of inspectors Regular training activities organised by PIC/S Open to PIC/S members, observers and partners Specific international inspector training on ICH Q7 Role of observed inspections EMA also supports training requests from ICH Supports selected requests from individual countries priority given to multilateral fora 31

32 EMA EU Network Training & Regulatory Capacity initiatives GCP and Pharmacovigilance Inspector Training activities Annual GCP training event organised by EMA in collaboration with EU regulatory network Representatives from up to 40 non-eu countries: countries such as Ghana, Nigeria, Canada, USA, Indonesia, Kenya, Japan, Korea and South Africa, Tanzania, Switzerland, China, Russia, Brazil, Bosnia and Herzegovina, Turkey, Montenegro and the Former Yugoslav Republic of Macedonia have attended. Opportunity for specific focussed training as well as building up networks Similar annual training for Pharmacovigilance inspectors since

33 13 February 2014 EMA/272045/2013 Patient Health Protection SmPC Guideline checklist SmPC Advisory Group The SmPC forms an intrinsic and integral part of the marketing authorization and is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. The scientific assessment should evaluate how the SmPC will optimize the benefits and manage the risks. This check-list aims to facilitate the translation of the scientific assessment into practical information for clinical practice based on the recommendation of the SmPC guideline. However, it should be read in conjunction with the complete recommendations of the SmPC guideline. The SmPC guideline and other information including training material to help reviewing of SmPCs are available on the EudraSmPC webpage: Name of product: Date of review: 33 Reviewer:

34 In conclusion the my (!) experience from EU collaboration is Takes time All about building trust and transparent procedures/assessments Training is essential A "healthy" competition is valuable Reward "good" performance No way the current work load could be handled by a single regulatory agency Stronger together Avoid repeating work if possible Global collaboration is the only way forward 34

35 European Medicines Agency 30 Churchill Place London E14 5EU Thank you! Any Questions??? 35