Registration of Veterinary Vaccines in the USA and Canada

Veterinary biological products, including vaccines, are regulated independently of veterinary pharmaceuticals and topical insecticides/pesticides in Canada and the USA. Three different acts, with associated regulations and guidance, govern the three different product categories, with the result that regulation is quite dissimilar. The requirements for licensing of vaccines with USDA and CFIA are also significantly different from those for licensing of vaccines in the individual EU member states, or centrally in the EU.

This intensive one-day course will explain the licensing process for vaccines with USDA and CFIA, and will provide comprehensive insight into the requirements to achieve a successful application.

The programme will address the transferability of EU dossiers for USDA submission, which will be beneficial in planning your regulatory strategy.

Benefits of attending:

• Gain a comprehensive insight into the difference of approach to licensing in the USDA/CFIA vs EU
• Understand the phased-submission process for vaccine licensing
• Learn the format and content specifications for the required dossier components
• Review the USDA regulations (9 CFR) and guidance – memoranda, notices, supplemental information formats (SIFs), supplemental assay methods (SAMs)
• Compare the regulatory fee structures for the USA and Canada
• Discuss the transferability of EU dossiers for USDA submission

Sponsored by

This programme will be key to all those working with veterinary vaccines who require an understanding of the licensing process in the USA and Canada, including:

• Regulatory affairs professionals
• Registration managers
• Global vaccines regulatory associates
• Programme managers for biologics
• Business development directors

Regulatory framework for veterinary vaccines in Canada and USA

• Biologics regulatory agencies and acts
  - CFIA and USDA, Health of Animals Act, Virus-Serum-Toxin Act
• Regulations
  - Code of Federal Regulations, Title 9 (9 CFR)
• Guidance
  - Veterinary services memoranda, public notices, risk analyses and SIFs, SAMs, policy manuals, submission compliance book, electronic submissions

Requirements for a US Veterinary Biologics Product License

• Categories of licenses issued by USDA CVB
• Basic licence requirements
• Phased submission process
  - Review/approval of documentation by CVB prior to advancement to next phase
  - CVB confirmatory testing and approval of master seeds, pre-licensing serials

• Regulatory fee structure

Transferability of EU dossiers for USDA submission

• Compare challenge and field study requirements
• USDA dossier for EMA submission

Recent changes to the regulations and guidance

Permits, establishment licence and inspections

• Imported products and permittee responsibilities
• US Veterinary Biologics Establishment License requirements

- Facility documentation, blueprints, plot plans, legends and addenda, personnel qualifications and experience

• Facility inspections by CVB Inspection and Compliance

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.