European Medicines Agency (EMEA) Introduction to the EMEA Introduction to the EMEA st EMEA workshop for micro, small and medium- 1 st EMEA workshop for micro, small and medium- sized enterprises (SMEs) sized enterprises (SMEs) 2 February 2007, EMEA 2 February 2007, EMEA
40 years of harmonisation 40 years of harmonisation • 1965 1965 1965 - First Directive set out basic principles irst Directive set out basic principles 1965 • • 1975 - 1975 - First pharmaceutical testing Directive irst pharmaceutical testing Directive • 1981 - 1981 - Specific veterinary legislation adopted pecific veterinary legislation adopted • 1985 – 1985 – ‘1992 Single Market’ project launched 1992 Single Market’ project launched • 1993 - 1993 - Council Regulation No 2309/93 adopted ouncil Regulation No 2309/93 adopted • 1995 1995 1995 - EMEA officially opens MEA officially opens 1995 • • 2001 - 2001 - Commission proposes ‘Review’ package ommission proposes ‘Review’ package • 2004 – 2004 – Part of new legislation comes into force art of new legislation comes into force • 2005 2005 2005 - New legislation came fully into force ew legislation came fully into force 2005 • • 2005 – 2005 – SME legislation came into force ME legislation came into force
The European system – Why? The European system – hy? • Complete single EU market for pharmaceuticals Complete single EU market for pharmaceuticals • Protect and promote public and animal health Protect and promote public and animal health • Facilitate access by patients to new & better Facilitate access by patients to new & better medicines medicines • Same product information for professionals and Same product information for professionals and for patients for patients • Benefit European R&D pharmaceutical industry Benefit European R&D pharmaceutical industry • Platform for discussion of public health issues at Platform for discussion of public health issues at European level European level
The European system – How? The European system – ow? • “One European system: two procedures” “One European system: two procedures” − Centralised procedure Centralised procedure − Mutual recognition and decentralised procedures Mutual recognition and decentralised procedures • EMEA is focal point of centralised procedure EMEA is focal point of centralised procedure • Rapid and EU-wide authorisation Rapid and EU-wide authorisation • 1 evaluation, 1 authorisation 1 evaluation, 1 authorisation • No price or reimbursement issues No price or reimbursement issues
A networking decentralised agency A networking decentralised agency • Member States have pooled their sovereignty for Member States have pooled their sovereignty for authorisation of medicines authorisation of medicines • EMEA is designed to coordinate the existing EMEA is designed to coordinate the existing scientific resources of Member States scientific resources of Member States • EMEA is not intended to replace national EMEA is not intended to replace national authorities, but to be a partner in the system authorities, but to be a partner in the system • A ‘virtual’ agency, providing an interface A ‘virtual’ agency, providing an interface between all partners between all partners • All parties linked by an IT network (EudraNet) All parties linked by an IT network (EudraNet)
Structure of the EMEA Structure of the EMEA Management Management Executiv Executive Management Management Executiv Executive CHMP CHMP CVMP CVMP CHMP CHMP CVMP CVMP Boa Board Director Dir ector Board Boa Director Dir ector Executive Support Executive Support Legal Sector Legal Sector COMP CO MP HMPC HMPC PDCO PDCO IQM/audit CO COMP MP HMPC HMPC PDCO PDCO IQM/audit Senior Medical Officer Senior Medical Officer EMEA Sec EMEA Secretariat etariat EMEA Secretariat EMEA Sec etariat Communications Communications Administration Administration Pre-authorisatio Pre-autho isation Post-authorisatio Post-aut horisation Veterinary Veterina ry Communications Communications Administration Administration Pre-autho Pre-authorisatio isation Post-authorisatio Post-aut horisation Veterina Veterinary ry and and Evaluation of Evaluation of Evaluation of Evaluation of Medicines Medic nes and and Evaluation of Evaluation of Evaluation of Evaluation of Medic Medicines nes Ne Networ tworking ng Human M Hu Medicine dicines Human M Hu Medicines dicines and and Ins Inspections ections Networ Ne tworking ng Hu Human M Medicine dicines Hu Human M Medicines dicines and and Ins Inspections ections Nati Na tion onal compe competent au ent auth thori orities EU institutio EU institut ions: ns: Na Nati tion onal compe competent au ent auth thori orities EU institut EU institutio ions: ns: Euro European experts pean experts Commission and Parliament Commissio n and Parliament Euro European experts pean experts Commissio Commission and Parliament n and Parliament
EMEA and its Europartners EMEA and its Europartners • Over 40 national authorities in 30 countries Over 40 national authorities in 30 countries dealing with human and veterinary medicines dealing with human and veterinary medicines • Network of over 4,000 European experts Network of over 4,000 European experts • EU institutions: European Commission, European EU institutions: European Commission, European Parliament, other EU agencies Parliament, other EU agencies • European Pharmacopoeia (Council of Europe) European Pharmacopoeia (Council of Europe) • Medicines Control Laboratories Network Medicines Control Laboratories Network
EMEA and national authorities EMEA and national authorities • European experts’ network underpins the work European experts’ network underpins the work of the scientific committees and working parties of the scientific committees and working parties • European experts work for EMEA independently European experts work for EMEA independently of their nominating authority of their nominating authority • Scientific competence is guaranteed by their Scientific competence is guaranteed by their nominating authority, independence and nominating authority, independence and integrity assured through public declaration of integrity assured through public declaration of interests interests • Services provided to EMEA on basis of a Services provided to EMEA on basis of a contract (conditions, quality and payment) contract (conditions, quality and payment)
EMEA and EU institutions EMEA and EU institutions • EMEA is a decentralised agency of the EU, not EMEA is a decentralised agency of the EU, not part of the European Commission part of the European Commission • EMEA adopts opinions EMEA adopts opinions on basis of scientific on basis of scientific criteria, Commission takes decisions criteria, Commission takes decisions based on based on that opinion that opinion • Commission must fully justify decision when it is Commission must fully justify decision when it is not in accordance with EMEA opinion not in accordance with EMEA opinion
EMEA and EU institutions EMEA and EU institutions • European Commission (mainly DG Enterprise and European Commission (mainly DG Enterprise and DG Health and consumer protection) DG Health and consumer protection) • European Parliament (Environment, public health European Parliament (Environment, public health and food safety committee) and food safety committee) • Other EU agencies such as the EMCDDA Other EU agencies such as the EMCDDA (narcotics agency), ECDC, EFSA, Translation (narcotics agency), ECDC, EFSA, Translation Centre, etc Centre, etc
EMEA priorities in 2007 EMEA priorities in 2007 • Safety of medicines for human and veterinary use Safety of medicines for human and veterinary use • Implementation of legislation on medicines for Implementation of legislation on medicines for children children • Stimulation of innovation Stimulation of innovation • Earlier and improved access to medicines Earlier and improved access to medicines • Transparency, communication and provision of Transparency, communication and provision of information information • The European medicines network The European medicines network
Recommend
More recommend
