[Photo by the Ministry of Food and Drug Safety website] Ministry of Food and Drug Safety
[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety (MFDS) has finalized guidelines for evaluating data manipulation by biopharmaceutical manufacturers to prevent a recurrence of the 'second Medytox' incident. Inspections will begin with manufacturers of botulinum toxin products, commonly known as 'Botox.'
On the 13th, the MFDS announced that it has finalized the 'Data Integrity Evaluation Guidelines' for biopharmaceuticals and will use them as a basis for penalties during investigations and crackdowns.
The MFDS expanded the scope of data management to include all generated materials related to Good Manufacturing Practice (GMP) for pharmaceuticals and required that data be managed and operated under the responsibility of management. Risk assessments will be conducted on test items vulnerable to data integrity issues and with a high possibility of falsification or manipulation.
The MFDS issued an administrative order for the industry to apply the evaluation guidelines starting from the 17th of next month. Failure to comply with the administrative order will be regarded as an attempt or act of data manipulation and will be dealt with under a zero-tolerance policy.
The MFDS stated, "To verify compliance with these evaluation guidelines, we will prioritize on-site inspections of botulinum toxin product manufacturers around November and expand the inspection targets through 2023."
The MFDS plans to expand the evaluation targets starting with botulinum toxin products this year, followed by pharmaceuticals subject to national batch release approval next year, recombinant gene medicines in 2022, and all biopharmaceuticals by 2023.
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