MFDS Confirms Cancellation of 'Medytoxine' Product Approval (Comprehensive)

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 18th that it will cancel the product approval for Medytox's botulinum toxin preparation 'Medytoxine' effective from the 25th.

The product approval cancellation targets three Medytoxine products: Medytoxine Injection, Medytoxine Injection 50 units, and Medytoxine Injection 150 units.

Medytoxine is the first domestically developed and the fourth worldwide botulinum toxin type A preparation, developed in 2006. It holds the number one market share in Korea and ranks among the top in several countries including Japan and Thailand, accounting for about 40% of Medytox's annual sales as a flagship product.

Earlier, the Ministry of Food and Drug Safety had suspended the manufacturing, sales, and use of the product as of April 17 and proceeded with administrative actions including product approval cancellation.

The Ministry decided to cancel the product approval because Medytox manipulated documents to make it appear as if the approved raw materials were used in the production process despite using different raw materials, falsely recorded potency test results of raw materials and products as compliant when they were out of standard, and submitted fabricated data to the Ministry to obtain national batch release approval and sell the product in the market.

Regarding Medytox's violation of the Pharmaceutical Affairs Act by falsifying manufacturing and quality control documents, the Ministry canceled the approval for the three Medytoxine products and imposed a fine of 174.6 million KRW in lieu of a three-month suspension of manufacturing operations for another botulinum toxin product, 'Innotox.'

Additionally, Medytox was ordered to recall and dispose of the three products whose approvals were canceled, and medical institutions storing these products were urged to actively cooperate with the recall.

The Ministry stated that it will respond with a zero-tolerance policy toward document falsification. It plans to establish and distribute management guidelines that can track change histories such as data creation, modification, deletion, and addition. Management of data will be strengthened not only for test results but throughout the entire testing process.

If pharmaceutical manufacturers or importers are found not complying with these management guidelines during on-site inspections, it will be considered an attempt to manipulate data and will be strictly punished.

The Ministry views this incident as an abuse of the current system where low-risk drugs are approved for national batch release based solely on document review without separate national testing. Therefore, even for the lowest-risk drugs, random manufacturing numbers will be selected for national testing to prevent attempts at document falsification.

Penalties for document falsification will also be strengthened. The restriction period for application for approval or authorization will be extended from the current one year to five years, and the criteria for punitive fines will be raised. Amendments to the Pharmaceutical Affairs Act will be pursued to cancel approvals if national batch release approval is applied for with falsified documents.

However, it was explained that there is little concern about the safety of the three products whose approvals were canceled. This is based on comprehensive consideration of the usage status of the products, domestic and international clinical papers on botulinum toxin preparations, and the characteristic that the drug shows effects for a certain period before being decomposed in the body, as advised by the Central Pharmaceutical Deliberation Committee.

This content was produced with the assistance of AI translation services.