An agency of the European Union

European Union Internal and International collaborationPre- ICDRA ConferenceNovember2010

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1. The EU Regulatory System

2. Internal EU collaboration mechanisms and outputs

3. The European Medicines Agency and international collaboration

4. Conclusion

CONTENTS

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1965: First EU Directive on basic principles of medicines approval protection of public health

1975: First EU Directive on human pharmaceutical testing

1981: Specific veterinary legislation adopted

1985: “1992 Single Market” project launched

1993: Council Regulation (EEC) No 2309/93 adoptedAgency establishedLondon chosen as its site

The EU Regulatory System45 Years of Harmonisation

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AustriaBelgiumBulgariaCyprusCzech RepublicDenmarkEstoniaFinlandFranceGermanyGreeceHungaryIcelandIrelandItaly

European Union (plus EEA) LatviaLiechtensteinLithuaniaLuxembourgNetherlandsNorwayMaltaPolandPortugalRomaniaSlovak RepublicSloveniaSpainSwedenUK

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Objectives of the EU pharma regulatory framework

• To complete the single EU market for pharmaceuticals

• To protect and promote public and animal health

• To facilitate access by patients to new & better medicines

• To allow further development of European based R&D pharmaceutical industry

• To provide a platform for discussion of public health issues at European level

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European Union PRE 1995

15 National Regulatory Authorities15 Separate National Assessments 15 Independent Marketing

Authorisations

- poor resource utilisation- divergent scientific opinions/

patient & doctor information

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Approval in 1 MS => National Authorisation system

Approval in n or all MSs =>EU Authorisation system

3 EU procedures: Centralised Procedure (CP)Mutual Recognition Procedure (MRP)Decentralised Procedure (DCP)

Route? Choice? Depending on type of product and authorisation history in EU

+Regulatory & marketing strategyCompany preferences etc …

European union post 1995New legislation in 1995 (amended 2004):

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EU Collaboration and WorksharingPrinciples of EU authorisation system based on common legislation, worksharing and efficient use of resources

Centralised procedure

•Rapporteur and co-rapporteur prepare assessment on behalf of CHMP

Mutual Recognition Procedure and decentralised procedure

•Reference Member State (RMS) performs first assessment, assessment recognised by others

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Other Collaboration and Worksharing examples

Inspections (GMP/GCP/GLP)

•Competent authority in one Member State inspects “on behalf of community”

Periodic Safety Update Reports - assessment

•Procedures for worksharing

Post authorisation changes – Variations

•Procedures for work sharing among Member States

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EU worksharing – the building blocks

Common legislation

Common scientific and technical standards irrespective of authorisation route

•Based on Common format – the CTD

•Harmonised scientific guidelines (ICH and EU)

Complemented by common European approach to manufacturing and inspection

• EU GMP guide – same as PIC/S• Single format for manufacturing authorisation, GMP

certificate

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EU collaboration – the outputs

European Public Assessment Reports

Concept extended to non-centralised products in 2005

Certificates of medicinal product (based on WHO scheme)

EudraGMP – database of all manufacturing authorisations for sites in the EU plus

GMP certificates for inspections performed by any EU authority (public access)

Article 58 scientific opinions (for medicines intended for non EU markets

EMA and international collaboration

“Creating synergies through Communication, Collaboration and Cooperation”

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Long term vision- creating synergies

Supporting a global approach to authorisation and supervision of medicines

• Based on ICH and WHO requirements

• Using existing partnerships and tools

Ability to rely on local regulators

• Assurance of equivalent approach to manufacture and control of medicines and authorisation and supervision of clinical trials, local pharmacovigilance

• Focus on where products are being manufactured and tested

• Support (through the European Regulatory network) for training and capacity building

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Tools to achieve the Vision

Bilateral

Confidentiality arrangements

Mutual recognition agreements (MRA)

Other ad hoc activities (TAS, TATFAR etc)

Multilateral

Cooperation with other regulators and stakeholders in other fora - ICH, WHO, EDQM, CIOMS, ISO, HL7, PIC/S, Accession activities

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ICH Objectives

ICH activities

• Co-operate in the area of pharmacovigilance, risk management, clinical data management, international standardisation activities

• Global Cooperation Group and Regulators Forum key mechanisms for achieving the long-term vision

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World Health Organisation (WHO)(Multilateral) objectives

– Pandemic interactions– Attendance at each others’ scientific meetings– Contribute to regulatory capacity building– Strengthen pharmacovigilance collaboration– Strengthen and streamline collaboration on

Article 58 medicinal products– Certificate of Medicinal Product developments– Discussions on a confidentiality arrangement

underway

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Non-ICH countries objectives

Strategy – support for multicountry activities in preference to individual country activities

• Accession activities – specific IPA project• APEC, ASEAN, ICH etc.• Invitations to training events• Encouraging networking• Ad-hoc responses to specific country requests• e.g. Pharmacovigilance training videoconference with

ANVISA• Capacity building with African countries (WHO AVAREF)

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European Medicines Agency actions in the clinical trial area

• GCP inspections in developing countries increasing• Contacts with local authorities (capacity building)• Annual GCP Ins training event (invite non-EU auth)• Strategy paper on acceptance of CT conducted in third

countries– includes a 3-year plan of activities (‘08-‘11) – Reflection paper published May 2010– Workshop September 2010

Specific pilot launched with FDA on GCP inspections• Information sharing on inspections• Collaboration on inspections: parallel, sequential, joint

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International collaboration aspects CTs

Need for a global approach to Clinical trials – from an ethical, design and data quality perspective

How to do this?

• Creating network of concerned regulators• Supporting training and capacity building• Mapping and linkages to related activities already

underway e.g. WHO, ASEAN,ICH, Tripartite initiative (Japan, China, South Korea) etc…

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API challenges

Promote global approach to GMP and supplier obligations

Collaboration with third country regulatory authorities

Support for capacity building

Cooperation with WHO and EDQM

Pilot inspection programme for APIs launched 08 (EU (6 EU countries, EMA, EDQM), US, Aus)

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GMP inspection challenges

Promote global approach to GMP

Collaborate with bilateral and multilateral partners (PIC/S WHO)

Mutual Recognition Agreements

Promote concept of observing inspections

Pilot joint inspection programme with FDA

Support for training, network and capacity building

ConclusionInternal EU and international collaboration based on

principles of mutual cooperation and efficiencies

Many of EMA’s international activities build on principles of EU collaboration

EU has 45 years experience of harmonisation and collaboration

Principles of EU cooperation can be used by other regions

Willing to share experience and learnings with other regulators

Continued collaboration with other regulators moves us towards the long term vision 22

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EEA Countries

Mutual Recognition Agreements Candidate Countries

International Conference on Harmonisation

Council of Europe

FDA

World Health Organisation

European Institutions

EMA - European and International Partners

Relevant links: www.ema.europa.euEPARs on EMA website

http://www.ema.europa.eu/htms/human/epar/eparintro.htm

Monthly reports – CHMP and Pharmacovigilance

nationalPARs on Heads of Medicines Agencies website

http://www.hma.eu/mri.html

EudraGMP http://eudragmp.emea.europa.eu

Article 58 procedure details: http://www.ema.europa.eu/htms/human/non_eu_epar/background.htm

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