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The American manufacturer's view on the EEC texts and harmonization
H A Draayer1, L J Hilsabeck, R H Miller
1SmithKline Beecham Animal Health, Lincoln, NE.
Developments in Biological Standardization
|January 1, 1992
Summary
The European Community (EC) is updating veterinary biological regulations, differing from U.S. standards. The Animal Health Institute (AHI) proposes an international working group to harmonize these veterinary drug regulations and prevent trade barriers.
Area of Science:
- Veterinary Medicine
- Regulatory Science
- International Trade
Background:
- Modern advancements facilitate global trade in veterinary biological products.
- The European Community (EC) is implementing new directives for veterinary biologicals, emphasizing quality, safety, and efficacy.
- These EC regulations differ significantly from current United States Department of Agriculture (USDA) licensing requirements.
Purpose of the Study:
- To highlight key differences between EC and USDA regulatory requirements for veterinary biologicals.
- To propose a collaborative international approach to harmonize these regulations.
- To prevent potential trade barriers in the veterinary biological market.
Main Methods:
- Comparison of EC and USDA regulatory requirements, including Good Laboratory Practice (GLP) safety tests, Good Manufacturing Practice (GMP), cross-contamination prevention, duration of immunity data, and raw material specifications.
- Proposal for the formation of an international working group comprising industry and government representatives.
- Suggestion for annual meetings to discuss standardization and implementation timelines.
Main Results:
- Significant differences exist between EC and USDA requirements for veterinary biologicals.
- EC regulations impose stricter standards in areas such as safety testing, manufacturing, and raw materials.
- Tight deadlines for implementing new EC requirements pose challenges.
Conclusions:
- Harmonization of veterinary biological regulations is crucial for international trade.
- An international working group can facilitate standardization and address trade barriers.
- Collaboration between regulatory bodies and industry stakeholders (e.g., FEDESA, AHI, CVMP, USDA) is essential to ensure product quality while reducing trade impediments.