South Korea simplifies new drug approval process, reduces redundant reviews for rare medicines

South Korea's Ministry of Food and Drug Safety (MFDS) is simplifying the procedures for new drug approvals and reviews. The initiative aims to accelerate the development and release of innovative medicines within the country.

A key change involves reducing redundant review processes for drugs that have already received approval as rare medicines. When such drugs subsequently undergo the new drug approval process, the MFDS will omit steps that have already been covered in the initial review. This measure is expected to save time and resources for pharmaceutical companies.

Furthermore, the ministry plans to refine and clarify the pre-application consultation procedures. This will provide a clearer pathway for companies seeking approval, ensuring they understand the requirements and can prepare their submissions more effectively. The MFDS stated that these revisions to the 'New Drug Product Approval and Review Procedures (Civil Servant Guideline)' are designed to support the swift development and launch of new drugs.