1. Reason for revision
Following the amendment (Law No. 18307 promulgated on 7/20/2021/enforced on 10/21/2021) of the Pharmaceutical Affairs Act including the contents for the legal basis of the Institutional Review Board (IRB) giving approvals to pharmaceuticals conditional on the submittal of results of clinical tests done to patients administered medications and conducting reviews of clinical tests entrusted, said amendment was needed to stipulate matters entrusted by said law and their enforcement including the procedure and conditions for approvals and criteria for operation of the IRB.
2. Major contents
A. Readjustment of the party to which submittal data for the approval of pharmaceuticals for aquatic animals are to be provided (Article 13 of the Draft)
In step with the entrustment of the right for authorization, etc. of pharmaceuticals manufacturing businesses for aquatic animals to the CEO of the National Fisheries Products Quality Management Service (NFQS) due to the revision (Ministry of Oceans and Fisheries (MOF) Ordinance No. 470 dated 2/26/2021) of the Rules for Handling Pharmaceuticals, etc. for Animals, the party to which materials for approvals of the Minister of Food and Drug Safety including the approval of aquatic animals pharmaceutical manufacturing business should be provided (as per applicants’ request) is to be changed from the President of the National Fisheries Research & Development Institute (NFRDI) to the CEO of (NFQS).
B. Allowing clinical test-executing institutions’ clinical test sample analysis (Article 26 of the Draft)
With regard to items for the sample analysis of clinical tests directly done by clinical test-executing institutions, conducting sample analysis of clinical tests is to be allowed without separate designation of an institution for such analysis for more efficient management of the business of clinical tests and sample analysis by clinical test-executing institutions.
C. Regulations on the procedure for designation of clinical test safety support institutions, criteria for their designation, and business to be done by them and IRB’s composition/operation, etc. (Articles 38-4/5 of the Draft)
In connection with provision of basis for the designation of clinical test safety support institutions and basis for composition of the IRB through the amendment (Law No. 18307 dated 7/20/2021) of the Pharmaceutical Affairs Act, the need for stipulation of regulations concerning them has arisen.
D. Coming up with the operational procedure for conditional approvals and reviews to be done on a priority basis (Articles 39, 39-2, 40, and 40-2 of the Draft)
Concerning the legal basis provided for conditional approvals, designation of those to be reviewed on a priority basis, and report on the result of execution of conditions concerning pharmaceutical items with the amendment (Law No. 18307 dated 7/20/2021) of the Pharmaceutical Affairs Act, the need for stipulation of the detailed operational procedure and scope of materials to be submitted, etc. has arisen
E. Coming up with the procedure for disclosing the result of review of pharmaceuticals-related approvals (reports) (Article 102-8 of the Draft)
In connection with the new regulation on the disclosure of the result of review of pharmaceuticals-related approvals examination (review) with the amendment (Law No. 18307 dated 7/20/20210) of the Pharmaceutical Affairs Act, the need for stipulation of those subject to the disclosure of result of examination (review) and procedure/method of disclosure has arisen.
