Pharmaceuticals

Proposed amendments to the "Regulation on Safety of Pharmaceuticals, etc."; (14 page(s), in Korean)

The Ministry of Food and Drug Safety (MFDS) is amending the "Regulation on Safety of Pharmaceuticals, etc." as follows:

A. Easing the reporting requirement for API changes (Article 17)

The threshold for allowing API (active pharmaceutical ingredients) changes to be reported rather than registered has been relaxed from "10-fold or more" to "more than 10-fold" for changes in batch size.

B. Simplifying packaging labeling requirements (Deletion of Article 71, Item 5)

Labeling requirements for 'specifications of active ingredients' on containers and packaging have been removed.

C. Strengthening supply chain management for national essential medicines (Insertion of Article 102-4)

The scope of medicines requiring a stable supply due to temporary surges in demand has been defined, even if they are not designated as national essential medicines.

D. Establishing operating rules for Korea Institute of Natural Products Safety Management and Research (Insertion of Article 103-2)

Procedures for collecting fees and actual expenses for Natural Products Safety Management and Research have been established, as prescribed by Prime Minister's decree under the Pharmaceutical Affairs Act.

E. Ensuring consistency across laws and regulations (Article 102-5, etc.)

Related articles have been reorganized following the amendment of the "Pharmaceutical Affairs Act" and "Regulation on Safety of Pharmaceuticals, etc."