Medicinal Products, Pharmaceuticals

Proposed partial amendments to the "Regulation on Safety of Pharmaceuticals, etc."; (26 page(s), in Korean)

The proposed amendments to the "Regulation on Safety of Pharmaceuticals, etc." are as follows:

A. Simplification of submission for Good Manufacturing Practice (GMP) conformity assessment (Article 4, 48-bis of the draft, and attached Form 4)

- 11 GMP submission requirements for Marketing Authorization will be simplified into 4 requirements including site master file, and in particular, for an imported API (biological product is excluded), the submission can be replaced with an internationally harmonized GMP certificate.

B. Simplification of API registration requirement (Article 15, 17 of the draft, attached Form 16 and 17)

- Existing API registration requirement, manufacturer 's certificate of origin or GMP conformity assessment, will be replaced with an internationally harmonized GMP certificate.

C. Improvement of verification • inspection for extension of GMP certificate validity (Article 48-quarter of the draft)

- A verification • inspection will be improved to extend the GMP certificate validity by verifying or inspecting by means other than on-site inspection, if the Minister of Food and Drug Safety recognizes that, for the reason including no history of significant change within the manufacturing site, as well as no natural disaster.