Veterinary pharmaceutical products

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". Language(s): Korean. Number of pages: 32, 68, 34 and 11

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).