Suggested Reading for Workshop
Return to Meeting Information Page for the September 2010 Vaccine Workshop
Key References (compiled June 2010)
[PDF]
Selected U.S. and International Regulations and Guidances
-
U.S. Code of Federal Regulations, 9 CFR: Animal and Plant Health Inspection Service,
U.S. Department of Agriculture
- Minimum Requirements for Biological Products (2006) [PDF]
National Institute of Infectious Diseases, Japan
- ICH Harmonised Tripartite Guideline
Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (1999)
[PDF]
International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use
- 21 CFR Part 610: General Biological Products Standards (2008) [PDF]
Food and Drug Administration, USA
- General Requirements for the Production and Control of
Live and Inactivated Vaccines intended for Fish (1994) [PDF]
European Medicines Evaluation Agency
- Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs (2005) [PDF]
Health Canada
- Requirements for Diptheria, Tetanus, Pertussis, and Combined Vaccines (1989) [PDF]
Amendments (2003) [PDF]
World Health Organization
|
