Korea MFDS Update
The Ministry of Food and Drug Safety announced the pilot operation of a new "Pharmaceutical Approval and Review Coordination Committee," which allows applicants to request adjustments when supplementary documentation is required during the pharmaceutical approval and review process.
Documents eligible for coordination requests are those related to safety and efficacy review, quality review, and data protection status. The Ministry of Food and Drug Safety will select the agenda items for the coordination committee meetings after a preliminary review. However, cases where regulations are clear or where advice from the Central Pharmaceutical Affairs Council has been sought or deemed necessary are excluded from the preliminary review process.
This coordination committee has been newly established to ensure greater transparency in the pharmaceutical product approval and review process. After a one-year trial period, a decision will be made on whether to transition to formal operation and whether to expand operations to include biopharmaceuticals and medical devices.
