(1) Reasons for Proposal
Revise the Regulation on Safety and Effectiveness Audit of Veterinary Medicines, etc., (Notice by the Quarantine Agency) in accordance with the amendment to the Rules for Handling of Veterinary Drugs, etc. (Revised on March 14, 2018, and to be enacted on September 15, 2019)

(2) Major Provisions
Data requirements for the review of safety and efficacy of veterinary drugs, etc. (Article 7)
○ Data about toxicity
- Data published in professional journals
- Data tested by non-clinical institutions designated by the Director of the Quarantine Agency
* In the case of foreign data, toxicological test data recognized to comply with the non-clinical trial management standards in attached Table 3 of the Regulations on Designation of Non-Clinical Institutions for Veterinary Drugs, etc.
○ Data about clinical trials
- Data published in professional journals
- Data tested by clinical institutions designated by the Director of the Quarantine Agency [tolerance test during phase 1 clinical trial (safety for target animals) and phase 3 clinical trial of clinical trial guidelines]
* In the case of foreign data, test data recognized to comply with the clinical trial management standards in attached Table 1 of the Regulations on Designation of Clinical Institutions for Veterinary Drugs, etc.
○ Data about efficacy test for disinfectant
- Data that are suitable for the efficacy test guidelines, which are tested in any one of the following entities:
① Data tested by non-clinical institutions designated by the Director of the Quarantine Agency
② Data tested in Office International des Epizooties (OIE) reference labs
③ Data on institutions with recognized credibility in carrying out testing in accordance with the management standards in attached Table 3 of the Regulations on Designation of Non-Clinical Institutions for Veterinary Drugs, etc.
.
○ Data about residue tests (residue tests for the establishment of drug-free intervals)
- Data published in professional journals
- Data tested by non-clinical institutions designated by the Director of the Quarantine Agency
* In the case of foreign data, those data recognized to comply with the non-clinical trial management standards in attached Table 3 of the Regulations on Designation of Non-Clinical Institutions for Veterinary Drugs, etc.
○ Data about bioequivalence tests
- Data tested by non-clinical institutions (including clinical sample analysis institutes) designated by the Director of the Quarantine Agency
 (Addendum) When conducting toxicity, residue, and bioequivalence tests or submitting a clinical trial plan prior to the Notice (before September 15, 2019), follow the previous Regulations.