The Ministry of Food and Drug Safety (MFDS) has announced a proposed amendment to regulations on pharmaceutical safety on November 29 to facilitate regulatory innovation in the pharmaceutical field. This draft is open for public opinion until January 28 next year.
● The key contents of the amendment proposal
1. When applying for a manufacturing permit for products under full-process outsourcing, exempt the submission of pharmaceutical manufacturing and quality management standards evaluation data, and allow the substitution of some documents with a statement of reasons when applying for approval for essential national medicines with no alternative.
2. Clearly specify the submission of necessary data for approval during the approval of the clinical trial plan.
3. Improve the reporting deadline for drug supply discontinuation from the current 60 days to 180 days in advance, require reporting even in the case of shortages, and strengthen administrative sanctions for failure to report.
4. Establish regulations for changes in matters included in the patent list, and set procedures and documents for submission when reporting the expiration of the effectiveness of preferential marketing authorization for listed items.
5. Revise the criteria for administrative measures to suspend business operations in case of failure to appoint, change, or report the discontinuation of a safety management officer.
6. Revise the format related to the determination of compliance with pharmaceutical manufacturing and quality management standards.
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