Introduction to the EMEA Introduction to the EMEA st EMEA workshop - - PowerPoint PPT Presentation

Introduction to the EMEA Introduction to the EMEA

European Medicines Agency (EMEA)

1st

st EMEA workshop for micro, small and medium-

EMEA workshop for micro, small and medium- sized enterprises (SMEs) sized enterprises (SMEs) 2 February 2007, EMEA 2 February 2007, EMEA

• 1965

1965 1965 1965 - First Directive set out basic principles irst Directive set out basic principles

• 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

• uncil Regulation No 2309/93 adopted
• 1995

1995 1995 1995 - EMEA officially opens MEA officially opens

• 2001 -

2001 - Commission proposes ‘Review’ package

• mmission proposes ‘Review’ package
• 2004 –

2004 – Part of new legislation comes into force art of new legislation comes into force

• 2005

2005 2005 2005 - New legislation came fully into force ew legislation came fully into force

• 2005 –

2005 – SME legislation came into force ME legislation came into force

40 years of harmonisation 40 years of harmonisation

• 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 – The European system – Why? hy?

• “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

The European system – The European system – How?

• w?

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 Boa Board Management Management Boa Board Executiv Executive Dir Director ector Executiv Executive Dir Director ector CHMP CHMP CHMP CHMP

Veterina Veterinary ry Medic Medicines nes and and Ins Inspections ections Veterina Veterinary ry Medic Medicines nes and and Ins Inspections ections Pre-autho Pre-authorisatio isation Evaluation of Evaluation of Hu Human M Medicine dicines Pre-autho Pre-authorisatio isation Evaluation of Evaluation of Hu Human M Medicine dicines Communications Communications and and Ne Networ tworking ng Communications Communications and and Ne Networ tworking ng Administration Administration Administration Administration

EMEA Sec EMEA Secretariat etariat EMEA Sec EMEA Secretariat etariat

Post-aut Post-authorisatio horisation Evaluation of Evaluation of Hu Human M Medicines dicines Post-aut Post-authorisatio horisation Evaluation of Evaluation of Hu Human M Medicines dicines Na Nati tion

• nal compe

competent au ent auth thori

• rities

Euro European experts pean experts Na Nati tion

• nal compe

competent au ent auth thori

• rities

Euro European experts pean experts EU institut EU institutio ions: ns: Commissio Commission and Parliament n and Parliament EU institut EU institutio ions: ns: Commissio Commission and Parliament n and Parliament

CVMP CVMP CVMP CVMP HMPC HMPC HMPC HMPC CO COMP MP CO COMP MP PDCO PDCO PDCO PDCO

Executive Support Legal Sector IQM/audit Senior Medical Officer Executive Support Legal Sector IQM/audit Senior Medical Officer

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

• European experts’ network underpins the work

European experts’ network underpins the work

• f the scientific committees and working parties
• f the scientific committees and working parties
• European experts work for EMEA independently

European experts work for EMEA independently

• f their nominating authority
• f 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 national authorities EMEA and national authorities

• 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

• n 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 and EU institutions EMEA and EU institutions

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