MFDS Rebuttal: "Medytoxine Is Not Exempt from National Batch Release Approval" (Comprehensive)

Medytox "MFDS Judged Export Products as Domestic Use"... MFDS "Importer's Request Is Required"

[Asia Economy Reporter Cho Hyun-ui] On the 20th, the Ministry of Food and Drug Safety (MFDS) stated in response to Medytox’s objection to the cancellation of the product approval for the botulinum toxin preparation ‘Medytoxyn’ that “Medytoxyn, which has not received product approval in China, is not exempt from national batch release approval.” This was a rebuttal to Medytox’s claim the previous day that “the MFDS judged the drug produced for export as for domestic use.”

An MFDS official said in a phone interview with Asia Economy on the same day, “To be exempt from national batch release approval, a request from the importing company must be made.” In fact, there was no such request, and since Medytox has not obtained formal approval from the National Medical Products Administration (NMPA) of China, it is structurally impossible.

Botulinum toxin preparations are drugs subject to national batch release approval. Even if approved, they must pass the national batch release approval, a kind of national inspection conducted by the MFDS to verify quality before distribution, in order to be marketed. Drugs sold without national batch release approval are subject to product approval cancellation under Article 53, Paragraph 1 of the Pharmaceutical Affairs Act.

Medytox was found to have sold not only Medytoxyn without national batch release approval but also products without Korean labeling. Considering the time required for the cancellation procedure, the MFDS ordered a provisional suspension of manufacturing and sales and requested immediate cessation of use at hospitals and clinics.

Medytox argued that drugs produced for export are not subject to the MFDS’s national batch release approval under the Pharmaceutical Affairs Act. Deputy Director Yang responded, “Medytox’s products without national batch release approval were smuggled into China through pharmaceutical wholesalers,” pointing out that “the problem ultimately lies in the smuggling into China.” In fact, since 2016, Medytox has been involved in a legal dispute over payment of approximately 10.5 billion KRW with domestic pharmaceutical wholesaler Company C, which exported and sold Medytoxyn to China, revealing the unauthorized export to China.

Medytox has been embroiled in allegations of illegal activities throughout the entire process from manufacturing and production to distribution and sales of botulinum toxin preparations. To make matters worse, following the cancellation of approval for Medytoxyn 50, 100, and 150 units in June due to unauthorized use of raw materials, the recent violation of national batch release approval has included Medytoxyn 200 units and Coretox in the cancellation targets, putting all Medytoxyn products and Coretox?which was expected to fill the gap left by Medytoxyn?at risk of cancellation.