1. Background of Promotion

- The current GMP evaluates based on dosage forms, and core elements of GMP advancement, such as validation and qualification, have not been introduced.
- Evaluating GMP by dosage form for new drugs, injections, biological products, etc., where safety management is critical, poses limitations in quality assurance for individual items.
- Without conducting validation and other essential processes, it is difficult to secure objective reliability regarding the quality of veterinary drugs, and there are also limits to process efficiency.
- It is necessary to manage veterinary drugs by reclassifying their types and requiring the submission of item-specific GMP evaluation data when applying for item marketing authorization.

2. Regulatory Content

- Introduce an item-specific GMP evaluation system, mandate validation and other requirements during GMP evaluation, and require the submission of item-specific GMP evaluation data when applying for item marketing authorization or item notification.
- When applying for veterinary drug manufacturing item marketing authorization, submit data related to manufacturing and quality, such as manufacturing plant floor plans, facility/environmental data, and validation, for the conformity assessment of GMP standards by type.
- Comply with manufacturing and quality control standards for each type of veterinary drug.