Pharmaceuticals

Partial amendment to the "Regulation for Pharmaceutical Approvals, Notifications and Reviews"; (22 page(s), in Korean)

The Ministry of Food and Drug Safety of the Republic of Korea intends to amend the following provisions of the "Regulation for Pharmaceutical Approvals, Notifications and Reviews"

A. If only the name of the "general test method" registered in the Korean Pharmacopeia or other official compendia notified by the Minister of Food and Drug Safety is changed, such change will be deemed to have been approved or notified. (Article 3-2)

B. A legal basis will be established to allow the stability data for medical high-pressure gases to be substituted by evidence from prior use of previously approved or notified products. (Article 7)

C. Provisions related to the Risk Management Plan (RMP) will be aligned with the amendment of higher-level legislation. (Article 7-2)

D. Eligibility for multiple specifications for an active ingredient will be expanded to include orphan drugs for which quality-related data have been submitted. (Article 12)

E. When obtaining approval for a new dosage form of an OTC drug with same route of administration, eligibility for reduced data requirements will be clarified by specifying what constitutes minor differences from previously approved/notified dosage forms. (Annex 1)