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Presentation of the directive 81/852/EEC (92/18) safety testing
1CNEVA/LCRAP: UR station de Pathologie Porcine, Ploufragan, France.
Developments in Biological Standardization
|January 1, 1992
Summary
This directive outlines essential safety testing for biological products, focusing on target species and recommended dosages. It ensures product safety through rigorous testing under normal and abnormal conditions, including reproductive and immunological assessments.
Area of Science:
- Veterinary Medicine
- Immunology
- Pharmacology
Background:
- Ensuring the safety of biological products is crucial for animal health.
- Manufacturers must conduct comprehensive safety assessments.
- Regulatory guidelines define the scope of these safety evaluations.
Purpose of the Study:
- To define standardized safety testing protocols for biological products.
- To ensure biological products are safe for target animal species.
- To provide manufacturers with precise information on product safety properties.
Main Methods:
- Testing biological products in target species at recommended doses and maximum potency.
- Utilizing samples from batches produced according to manufacturing processes.
- Evaluating safety under normal and abnormal conditions (e.g., overdose, repeated administration).
Main Results:
- Objective criteria are established to measure adverse general and local effects.
- Studies include effects on reproductive function, progeny, and immunological function.
- Specific requirements for live vaccines address strain dissemination, spread, and reversion to virulence.
Conclusions:
- Standardized safety testing is essential for biological product approval.
- Comprehensive testing protocols ensure product safety in target animal populations.
- Field studies offer valuable complementary safety data.