1. Reason for Revision
The revision aims to rationalize and ease regulations based on industry demand related to safety testing of veterinary medicines, as well as the comparison of domestic and international standards. It includes introducing a provision to omit certain tests for formulations with the same active ingredient and dosage form, among other adjustments.
2. Legal Basis and Related Legislation
*Pharmaceutical Affairs Act: Article 31, Article 42, Article 85, Paragraph 1
*Veterinary Medicines Handling Rules: Article 7, Paragraphs 1 and 2
*Regulations on Safety and Efficacy Review of Veterinary Medicines: Article 7, Paragraph 1, Item 3
1) Key Amendments
a. Inclusion of Animal Cell Therapy and Animal Gene Therapy in the Definition of Biological Products (Article 2, Paragraph 7)
- The definition of biological products is updated to include animal cell therapies and animal gene therapies. Additionally, the term “expiration date” is revised to “use period” to reflect more accurate terminology, covering use period, expiration date, or retesting period for raw materials.
b. New Test Standards for New Drugs, Photostability Tests, and Stability Tests for New Formulations (Article 3, Paragraph 6, Annex 4, 5)
- New test standards are introduced for photostability tests for new drugs and stability tests for new formulations of veterinary medicines. Guidelines for submitting only partial stability test data for new formulations are established, and these are reflected in Article 3, Paragraph 6.
c. Introduction of Omission Provision for Tests in Formulations with the Same Active Ingredient and Dosage Form (Article 4, Annex 2, 3)
- A new provision is introduced allowing the omission of certain tests for formulations with the same active ingredient and dosage form (including formulations with different amounts of the active ingredient). Detailed criteria for this omission are outlined in the bracket design (Annex 2) and matrix design (Annex 3).
d. New Review Deadline for the Validity and Improvement of the Guidelines (Article 7)
- A new deadline for the review of the validity and improvement of the guidelines is introduced in Article 7.
e. Relocation and Adjustment of Previous Articles and Annexes
- Following the introduction of Article 4 (Omission of Tests), previous Articles 4, 4-2, and 5 are moved to Articles 5, 5-2, and 6, respectively. The previous annexes are renumbered to Annex 1, and a decision-making flowchart for the use period application is added.
