EU Enlargement

1
European Partnership for Alternative Approaches
to Animal Testing (EPAA)
Working Group 4 Workshop on Medicinal
Products Brussels, 12 October 2006 Rui Santos
Ivo Pharmaceuticals Unit European Commission - DG
Enterprise

2
The Regulatory Framework for Medicinal Products
in the European Union

• EU Community Legislation
• Practical implementation
• Scientific Guidance
• International activities

3
Community legislation in the field of medicinal
products

• Protection of public and animal health
• Free movement of medicinal products within the
  Community

4
Community legislation in the field of medicinal
products

• What is EC legislation
• Regulations directly binding
• Directives binding to the effect, not the means
• Decisions binding upon those they are addressed
  to

5
Community legislation in the field of medicinal
products

• Soft law
• Guidelines
• Texts covering technical topics
• Different legal status
• Binding resulting from EC law
• Non binding drawn up by scientific committees
• -

6
Legal framework for medicinal products - History

• Progressive harmonisation since 1965 Directive
  65/65/EEC ? Codified Directive 2001/83/EC
• Centralised procedure available since 1995
  Regulation 726/2004 (organisation of EMEA)
• Mutual recognition compulsory since 1998
• Codification exercise in 2001
• 2005 Revised pharmaceutical legislation

7
Legal framework for medicinal products

• Main legislation
• Technical aspects included in the Codes for human
  and veterinary medicines
• Directive 2001/83/EC amended by Directives
  2004/24/EC and 2004/27/EC
• Directive 2001/82/EC, amended by Directive
  2004/28/EC
• Harmonisation at Community level (EUEEA)
• Regulation (EC) N. 726/2004

8
Tissues / Cells 2004/23/EC
Other starting materials
Blood2002/98/EC
Medical Devices 93/42/EC
Clinical Trials 2001/20/EC
Medicinal Products Community Code Dir. 2001/83/EC
Medicinal Products Centralised procedure Reg.
726/2004
GMP 2003/94/EC
Paediatrics
Orphans 141/2000
Variations 1084/2003 1085/2003
Annex I 2003/63/EC
Proposal onAdvanced TherapyProducts
9
Legal framework for medicinal products

• Pharmaceutical legislation
• Establishes legal requirements for the evaluation
  and control of medicinal products
• QSE quality, safety and efficacy
• Practical implementation dealt with by means of
  guidelines harmonised at EU level and/or
  international level

10
Legal framework for medicinal products

• Pharmaceutical legislation
• Prior marketing authorisation for each medicinal
  product
• Assessment of QSE quality, safety and efficacy
• Manufacturing process GMP
• Quality control market surveillance

11
Legal framework for medicinal products

• Practical implementation
• Guidance issued by the European Commission
• Scientific guidelines prepared by the Scientific
  Committees of the EMEA
• Committee for Medicinal Products for Human Use
  (CHMP)
• Committee for Medicinal Products for Veterinary
  Use (CVMP)

12
Legal framework for medicinal products

• Practical implementation
• The European Pharmacopoeia
• The EDQM/OMCL/BSP activities
• International harmonisation
• MRA
• ICH
• VICH

13
Legal framework for medicinal products

• Current initiatives from ENTR/F/2
• Review of ICH Safety (non-clinical) guidelines
• Consider opportunities for reduction, refinement
  or replacement of animal studies
• ICH Steering Committee Meeting, June 2006
• EU CHMP/SWP conducted in 2005/2006 a systematic
  evaluation of guidelines requiring updating

14
Legal framework for medicinal products

• Current initiatives from ENTR/F/2
• EU proposal to VICH to scrutinise guidelines
  concerning implementation of 3R principles
• Launch of VICH review process July 2006
•