The EU system for marketing authorition - EFPIA
[Pages:29]2017 China/EU Pharmaceutical Industry Forum
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Shanghai 17 May 2017
The EU system for marketing authorition
Patrick Deboyser
Minister-Counsellor ? EU Delegation to Thailand DG SANTE ? European Commission
2017 China/EU Pharmaceutical Industry Forum
The EU system for Marketing Authorization
Key Principles of EU Pharmaceutical Law & Policy
Shanghai 17 May 2017
Objectives
Protection of public health
Free movement of medicinal products within the EU
2017 China/EU Pharmaceutical Industry Forum
The EU system for Marketing Authorization
Key Milestones
Shanghai 17 May 2017
1965
First EU legislation on medicinal products.
To prevent a recurrence of the thalidomide disaster
To safeguard public health by not allowing medicinal products ever again to be marketed without prior authorisation
Authorization only granted after demonstration of the: safety, efficacy and quality of the product
1995
Establishment of: The EU centralized authorization system for medicinal
products The European Medicines Agency (EMA)
2017 China/EU Pharmaceutical Industry Forum
The EU system for Marketing Authorization
Key Actors
LEGISLATION
Proposal:
Adoption:
+
European Commission
European Council
Implementing Acts:
European Parliament
Interpretation:
+
European Commission
Committee of EU MSs
European Court of Justice
Shanghai 17 May 2017
2017 China/EU Pharmaceutical Industry Forum
The EU system for Marketing Authorization
Key Actors
AUTHORIZATIONS
Centralised Procedure
Application to:
Decision:
Shanghai 17 May 2017
European Medicines Agency EMA
+
European Commission
Appeal:
Committee of EU MSs
European Court of Justice
2017 China/EU Pharmaceutical Industry Forum
The EU system for Marketing Authorization
Marketing Authorizations
Shanghai 17 May 2017
A medicinal product may only be placed on the market in the European Union when a marketing authorisation has been issued:
? by the competent authority of a Member State (National authorisations) or ? by the Commission for the whole EU (Union authorisation).
Authorisations are granted on the basis of the criteria of QUALITY, SAFETY and EFFICACY
2017 China/EU Pharmaceutical Industry Forum
The EU system for Marketing Authorization
Application requirements
Shanghai 17 May 2017
Module 1
Admin & Prescribing Information
Module 2
NonClinical Overview
Clinical Overview
Quality overall summary
NonClinical Overview
Clinical study
Module 3 Quality
Module 4
Non Clinical Study Reports
Module 5
Clinical Study Reports
Authorisation of medicines in the
EU reflects the internationally agreed standards
EU?CTD (Common Technical
Document) presentation is applicable irrespective of the type of procedure (centralised, mutual recognition or national).
Companies need to submit data of
tests and trials, demonstrating the Efficacy, Safety and Quality of the medicinal product.
2017 China/EU Pharmaceutical Industry Forum
The EU system for Marketing Authorization
The procedural set-up
Shanghai 17 May 2017
Approval in one Member State
National Authorisation
Approval in several or all Member States
Mutual Recognition Procedure (MRP) Decentralised Procedure (DCP) Centralised Procedure (CP)
ROUTE? CHOICE?
Depends on: ? Type of product ? Authorisation history in EU ? Regulatory & marketing strategy ? Company preferences etc ...
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