Proposed regulations: "The designation regulation of the clinical trial institution for veterinary pharmaceutical products"; "The designation regulation of non-clinical trial institution for veterinary pharmaceutical products"; "The designation regulation of the clinical trial institution for veterinary medical devices"; "The guidelines of the clinical trial for veterinary medical devices"
Regular notification
2019-04-29
G/SPS/N/KOR/636
Description
The proposed regulations seek to:
- Ensure the reliability of "Dossier" to be submitted to get an approval for veterinary pharmaceutical products;
- Describe the detailed regulations on the designation of the clinical trial institution and the non-clinical trial institution for the veterinary pharmaceutical products;
- Describe the detailed regulations to get an approval for the veterinary medical devices (writing and approval of the clinical trial protocol, the qualification of the principal investigator).
Keywords
Veterinary
drugs;
Animal
health;
Animal
diseases