[Background]
1. Clarifying the scope and required safety/efficacy submission data for veterinary drugs used in minor animal species to facilitate rapid item approval.
2. Clarifying the types of manufacturing process data and the review standards to be submitted when applying for item approval of biological products (vaccines).
3. Clarifying the review criteria for veterinary drugs by distinguishing between those subject to and exempt from the safety/efficacy review when the type or quantity of additives is not identical.
[Main Points]
1. (Minor Species) Improving Item Approval for Veterinary Drugs Used in Minor Species by Establishing a Definition and Revising the Scope of Safety/Efficacy Submission Data
Establishing the definition of "minor species" (Draft Article 2)
Defining minor species as animals excluding cattle, pigs, chickens, dogs, and cats.
Exempting certain data requirements when already approved veterinary drugs are used in minor species without changes in composition, route of administration, or dosage form (Draft Article 6, Subparagraph 4, Annex 2).
In cases where veterinary drugs approved for cattle are used in minor ruminant species.
In cases where veterinary drugs approved for chickens are used in minor avian species.
In cases where already approved veterinary drugs are used in minor species.
(Scope of Data Exemption) ① Stability data, ② Toxicity test data, ③ Pharmacological test data (efficacy test, general pharmacology test), and ④ Residue data (environmental impact assessment data).
2. (Seed Lot System) Establishing Criteria for Submission Data and Review Standards for Manufacturing Methods in relation to the Introduction of the Vaccine Seed Lot System
Data submission requirements for the manufacturing method of biological products (Draft Article 9-2, Paragraph 5)
Includes data on the origin, characteristics, and management method of the microbial strains/cells used for manufacturing, the manufacturing process and quality control of the target product, and proof of the absence of extraneous microbial contamination during the manufacturing process, etc.
Establishing new review standards for biological products related to the introduction of the Vaccine Seed Lot System (Draft Article 14-4)
Detailed specifics for each data category, including data on structure and components, data on physicochemical and biological properties, data on the manufacturing method, and standards and test methods (supporting data).
3. (Generic Drugs) Strengthening Veterinary Drug Safety by Classifying items with non-identical types/quantities of additives as subjects for Safety/Efficacy Review (Draft Article 3, Paragraph 2, Subparagraph 10 & 11)
