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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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