Overview of the EU regulatory system and governance PANDRH Conference – 5 September 2013 Ottawa Presented by: Alexios Skarlatos European Medicines Agency – Head of Product Information Quality

CONTENTS Approval of medicines in the EU EU assessment collaboration: Organisational aspects EU assessment collaboration: Enablers and facilitators 2

1. Approval of medicines in EU

Marketing Authorisation (MA) A medicinal product may only be placed on the market in the EU, when a marketing authorisation has been issued by the competent authority of an EU Member State or by the European Commission (via EMA) Structure of MA Application 4

EU cooperation in MA assessment: evolution 1970s-80s: First EU initiatives to encourage communication, cooperation and recognition of assessments between Member States ‘Multi-State’ and ‘Concertation Procedures’ Final national Member State decision 1990s: Creation of the European Medicines Agency (1995) Introduction of the ‘Centralised Procedure’ (1995) and the ‘Mutual Recognition Procedure (1993; mandatory from 1998) 2000s: Revision of Pharma legislation (required after 6y experience) Adapt and prepare for enlargement of EU Introduction of the ‘Decentralised Procedure’ 5 5

Drivers of Harmonisation The global pharmaceutical market -> effective operation of the internal market Pharmaceutical industry -> facilitate the free movement of medicines Scientific culture Patient involvement Need for worksharing -> avoid unnecessary duplication of efforts Fear of the unknown - insecurity

Obstacles to harmonisation Giving up sovereignty Need for compromising Heterogeneous cultures Language issue Uneven levels of capacity/experience Uneven share of the workload

Current Marketing Authorisation procedures in EU Approval in 1 MS => National Authorisation procedure Approval in n or all MSs => EU Authorisation procedure 3 EU procedures: Centralised Procedure (CP)  1 single EU MA Mutual Recognition Procedure (MRP) Decentralised Procedure (DCP)  n national MAs Route? Choice? Depending on type of product and authorisation history in EU + Regulatory & marketing strategy Company preferences etc …

Eligibility to the Centralised Procedure “Mandatory Scope” Biotech products - New Active Substances for Cancer, Diabetes, AIDS, Neurodegenerative, viral and auto-immune diseases - Orphan medicinal products - Cell & gene therapy + tissue engineered products “Optional Scope” - Other new active substances - Innovative uses of ‘old’ substances - Interest of patients at EU level - Generics of centrally-authorised products

2. EU assessment collaboration: Organisational aspects 10

National Competent Authorities (NCAs) EMA and the European Regulatory Network EMEA Secretariat Working Parties Committees National Competent Authorities (NCAs)

Resources in the Centralised Procedure National Competent Authorities (NCAs) in 28 EU Member States. EMA not intended to replace NCAs, but to be a trusted partner in the EU Regulatory Network > 3500 scientific experts nominated by Member States Available for scientific work & assessments for EMA Scientific committee (CHMP) delivers a final opinion Multidisciplinary assessment teams in MS to perform assessment (as Rapporteur/Co-Rapporteur) or participate as ‘peer reviewer’ Services are provided to EMA on the basis of a cooperation agreement All agencies linked by secure IT network (EudraNet) Fees received by EMA  payment of (Co-)Rapporteur

CHMP: Committee for Medicinal Products for Human Use Chair and Vice Chair + 1 member + 1 alternate/MS max. 5 co-opted members accompanied by experts                                                                                                                                   Ian Hudson Vice-Chair CHMP Tomas Salmonson Chair CHMP + 5 co-opted members 13

Support for MRP & DCP: Coordination group Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) Initially, voluntary ‘Mutual Recognition Facilitation Group’ Recognised and legal mandate in EU legislation revision Representatives of all Member States Agree on common rules procedural / regulatory matters Guidance to applicants Discuss and solve scientific issues during MRP/DCP EMA: secretariat, organisation of monthly meetings at EMA

3. EU assessment collaboration: enablers & facilitators 15

Harmonised legal requirements (high level) for Marketing Authorisation Application Harmonisation of technical standards and requirements ICH guidelines, incl. eCTD CHMP scientific guidelines - applicable to CP, MRP, DCP Provision of regulatory guidance Agreement on common approaches & procedures Commission guidelines CHMP and EMA guidance documents, Q&As, SOPs  Advice to applicants  Consistent approach/interpretation between Member States 16

Common templates for assessment reports Working together in expert Working Parties or ad-hoc groups e.g. Quality Working Party GCP inspectors working group Training of assessors Common templates for assessment reports ‘Twinning’ projects, e.g. for new EU Member States Years of confidence building, working together, worksharing Oversight and management by ‘Heads of Medicines Agencies’ (HMA) Group Secure communication tools and databases 17

Member State cooperation in MRP and DCP «Coordination Group for Mutual Recognition and Decentralised Procedures» CMDh, since Nov 2005 Replaces the informal MRFG group Coordination and facilitation of the operation of MRP and DCP Discussions on procedural/regulatory issues, guidance docs + scientific discussions on applications where MSs disagree Ensure consistency of standards and good decision-making Avoid referrals to EMA 18

Disagreements in MRP and DCP: only on the basis of ‘potential serious risk to public health’  Commission Guideline: definition and examples  CMDh: ensure common understanding and application Harmonisation of national SmPCs of originators, in order to facilitate approval of generics accross EU Commission guidelines on MRP and DCP procedures + CMDh publication of ‘Best Practice Guides’ Procedural guidance documents Q&A Worksharing and working group initiatives, coordinated by CMDh e.g. on PSURs and Active Substance Master Files 19 19

Head of Product Information Quality + 44 207 418 8682 Thank you Alexios M. Skarlatos Head of Product Information Quality + 44 207 418 8682 alexios.skarlatos@ema.europa.eu 20