Vaccines for OIE List A and Emerging Animal Diseases

Bluetongue Survey

NVSL: International Laboratory Diagnostic Support

The Center for Veterinary Biologics: Sharing International Information

National Center for Import/Export as an International Information Gathering and Disseminating Body

CEAH Trade Risk Analysis

VS CEAH Trade Risk Analysis/OIE Information Sharing

The Center for Veterinary Biologics: Sharing International Information

VS' CVB works to reduce trade practices that limit the sale of veterinary biological products overseas. Program officials continued technical and harmonization discussions with regulatory officials and with representatives of the American, Asian, European, and U.S. biologics industries. VS held individual meetings with regulatory officials from Australia and New Zealand to facilitate the exchange of information and encourage discussions of regulatory issues.

Interaction with Canadian regulatory officials continued under the Canada-United States Trade Agreement and the North American Free Trade Agreement. Officials have prepared and reviewed a memorandum of understanding and have planned meetings for FY 2003 to continue discussions about issues of mutual interest.

During FY 2002, the 10th Steering Committee Meeting of the Veterinary International Cooperation on Harmonization was held to review the progress of five working groups addressing projects concerning the harmonization of quality test requirements and post-licensing monitoring procedures (pharmacovigilance) for veterinary biological products. Guidance documents for formaldehyde and moisture testing were released for simultaneous implementation in Japan, the European Union, and the United States. Draft guidance documents on pharmacovigilance and mycoplasma testing were approved by the Steering Committee. The Biological Quality Monitoring working group continues work on harmonized guidelines for extraneous virus testing and the Target Animal Safety working group continues to make progress on a harmonized guidance document for safety testing.

In FY 2002, CVB continued working with the Committee of the Americas for the Harmonization of Registration and Control of Veterinary Medicines (CAMEVET). This committee consists of representatives of the Official Services from the OIE member countries in the Americas responsible for regulating veterinary medicinal products. The objectives of CAMEVET include the coordination of the technical information for the registration and control of veterinary medicines with the intention of exchanging information and harmonizing technical procedures to improve the quality of the veterinary medicines and the trade of the products among the countries in the Americas. CVB officials attended the annual meeting in Merida, Mexico, in August 2002, at which they presented program information on other harmonization efforts and adventitious agent testing.

VS sponsored an international symposium on vaccines for OIE List A and Emerging Animal Diseases, in Ames, IA. The meeting drew participants from around the world with the primary purpose of reviewing the availability, safety and efficacy of veterinary vaccines for OIE List A diseases and for selected emerging animal diseases.

CVB continued, in FY 2002, to emphasize in vitro potency testing of veterinary biologics. The CVB personnel participated in international meetings on in vitro testing and provided specific reagents for the development of international standards. Work continued towards establishing a national reference concept to facilitate antigen requalification. A reference to the third infectious bovine rhinotracheitis (IBR) glycoprotein immunogen was produced, completing the establishment phase of this project. Qualification work continued and a pilot study for immunogenicity of the host animal with the gD antigen was successfully completed.

The development of these procedures will result in a significant reduction in the use of animals in the testing and production of veterinary biological products. Additional reduction of animal use will result from a contract issued to Michigan State University to test a reference vaccine for Leptospira canicola and Leptospira icterohaemorrhagiae in dogs, which will provide a means for biologics firms to eliminate host animal testing to qualify references for in vitro serial release potency assays.

To continue progress in the accreditation of CVB Laboratory to International Standards Organization Guide 17025, CVB conducted internal audits and tested internal corrective action procedures. CVB also conducted a "gap analysis" and will use the findings and responses to prepare for external audits required for accreditation. CVB expanded and refined electronic monitoring and document control systems, and completed additional safety, administrative, and technical documentation. CVB Laboratory, along with NVSL, were reaccredited by the Association for Assessment and Accreditation of Laboratory Animal Care—International (AAALAC).