International harmonisation of regulatory requirements

Area of Science:

• Veterinary Medicine
• Regulatory Science
• Animal Health

Background:

• The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) was established in 1996.
• VICH is a collaborative program involving regulatory authorities and animal health industries from the EU, Japan, and the USA, with Canada and Australia/New Zealand as observers.

Purpose of the Study:

• To harmonize technical data requirements for veterinary medicinal products among participating regulatory authorities.
• To facilitate the granting of marketing authorization and registration for veterinary drugs globally.

Main Methods:

• Development and finalization of technical guidelines for product registration.
• Establishment of expert working groups to address specific areas of harmonization.
• Ongoing development of new guidelines based on evolving needs.

Main Results:

• VICH has finalized six guidelines for the registration of biological veterinary products, which have been fully implemented.
• Three additional technical guidelines for product registration are currently under development.
• One guideline on pharmacovigilance for veterinary medicinal products, including biologicals, has been finalized.
• Four further pharmacovigilance guidelines are in development.

Conclusions:

• VICH has successfully harmonized key technical requirements for veterinary medicinal products.
• Ongoing efforts are focused on expanding harmonization to include pharmacovigilance and other critical areas.
• The program promotes efficient and consistent regulatory processes for animal health products internationally.