Korea MFDS Update
The Ministry of Food and Drug Safety (MFDS) issued a legislative notice on July 5, 2024, that it will partially amend the Rules on the Safety of Pharmaceuticals, etc.
Public opinions on this amendment will be collected until September 5, 2024.
The main contents of this amendment are as follows.
• The submission documents required for compliance assessment with manufacturing and quality control standards will be improved.
• As a requirement for the registration of raw pharmaceutical ingredients, the submission of GMP assessment data will be streamlined to the submission of internationally recognized GMP certificates.
• The verification and investigation system for extending GMP compliance assessment will be improved.
