欧盟药政法规及产品注册的程序和要求

Scientific committees supported by working parties (WPS)
• Quality WP (joint human/veterinary ) • Biologics WP (formerly biotechnology WP) • Safety WP • Efficacy WP • Pharmacovigilance WP
赫尔曼·范龙佩, 欧洲理事会常任主席(右一)
European Regulatory Organization
EU Committee
EU Parliament
EU Committee
EU Commission
EMA (EMEA) (European Medicines Agency)
EDQM (European Directorate for the Quality of Medicine & Healthcare)
“Rule control Life”
Pharmaceutical legislation-background
Thalidomide Event -1960
European Pharmaceutical Legislation System-evolution
• 1965/65/EEC • 1975/318/EEC, 1975/319/EEC • 1993/93/EC • 2001/83/EC • 2004/426/EC, 2004/24/EC, 2004/27/EC
-E.G. Directive 65/65/EEC(now 2001/83)
• Decisions-binding on those to whom they are
addressed -E.G. Centralised marketing authorisations
• Recommendation and opinions –not binding
EMEA Secretariat
Committee for veterinary Medicinal products (CVMP)
Committee for Orphan Medicinal products (COMP)
New scientific committees of the EMEA
European Pharmaceutical Legislation System
• Treaty –binding to all of the member states
• Regulation –directly binding
-E.G. Regulation 2309/93
• Directive –binding as to the result achieved
(4000 European Experts )
EU Institution:
Commission-parliament-council
Management Board
Committee for Herbal Medicinal products (HMPC )
Committee for Human Medicinal products (CHMP)
1. The regulatory structure for the medicinal product
The European Union
• Total area: 4.322 million sq.km. • Countries : 27 • Population: over 5亿 • GDP：Over 1.2 trillion USD
• Committee for paediatric Medicinal products (2006)
• Committee for advanced therapy Medicinal products (2007)
ATMP is new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering).
European Pharmaceutical Legislation System
• More than 500 guidance covering the regulatory, CMC, preclinical and clinical technical requirement.
CEP/COS
OMCL
EP Phr
Authorization
National Authorities
百度文库
Inspection
OMCL
National Phr
OMCL: Official Medicines Control Laboratories
How is EMA organized?
27 National competent Authorities
Overview of the Regulation for the Medicinal Products in the EU
Outline of Presentation
1. Regulatory structure 2. Marketing authorization 3. How to prepare the documents 4. Traditional herbal product/TCMs 5. Tasly’s practice & experience
EMA
• About 360 staff members • –Operates in partnership with national
competent authorities (health authorities) • –Scientific network of approx 4000
European experts who assist the Agency in performing its scientific tasks