If Caught Obtaining Drug Approval with False Data, License Will Be Revoked... MFDS Announces Draft Amendment for Public Comment

[Asia Economy Reporter Choi Dae-yeol] The Ministry of Food and Drug Safety announced on the 29th a legislative notice for the amendment of the "Regulations on the Safety of Pharmaceuticals, etc." to establish administrative disposition standards that allow the cancellation of drug approvals obtained through fraudulent means, such as submitting false data.

The amendment was prepared to stipulate matters delegated by the Pharmaceutical Affairs Act, which was revised last April, including measures to prevent recurrence by strictly punishing deceptive acts such as falsification of drug manufacturing and quality control documents. If approval is obtained through false or fraudulent means or clinical trial plan approval is granted improperly, the approval will be subject to cancellation. Even when false data is submitted during national batch release approval for vaccines, cancellation of approval will be possible. The previous penalty of a 3-month suspension of manufacturing operations applied when manufacturing and quality control records were falsified will be removed and replaced with a 6-month suspension or cancellation of approval.

Furthermore, among national essential medicines, if supply is interrupted and there is no domestic substitute causing concerns about patient treatment disruption, the test reports from the original overseas manufacturer can be used to replace tests by domestic importers, similar to rare medicines. Considering that the deadline for reporting changes in raw pharmaceutical ingredients is at the end of January each year, causing a concentration of submissions, the deadline will be extended to the end of the month corresponding to the product registration date. Additionally, penalties for minor violations will be mitigated. Opinions on the amendment can be submitted until August 28.

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