"Document Forgery Is a Serious Deceptive Act" Strictly Punished

MFDS Confirms Cancellation of Medytox's 'Medytoxyn' Product Approval

Repeated Manipulation from 2012 to 2015
Products Generating 100 Billion KRW Annually Withdrawn
Permit System Supplemented with Change History Tracking

The appearance of Medytox's 3rd factory.

[Asia Economy Reporters Choi Dae-yeol, Cho Hyun-ui] The Ministry of Food and Drug Safety (MFDS) decided to revoke the approval of Korea’s first domestically produced botulinum toxin product, 'Medytoxine,' reflecting a strict stance against acts that deceive regulatory authorities such as document manipulation. Although some in the medical and industry sectors argued that withdrawal was excessive considering the low toxicity and market conditions, the deliberate falsification of documents was deemed unacceptable. To prevent recurrence, the MFDS plans to specify the necessary data in the approval process to eliminate manipulation possibilities and strengthen administrative sanctions against similar violations.

Medytoxine, Producing 100 Billion KRW Annually, Withdrawn from Market

According to the MFDS, the three products whose approvals were revoked this time (Medytoxine Injection, Medytoxine Injection 50 units, and 100 units) have an annual production scale reaching 100 billion KRW. As of 2018, it was 108.3 billion KRW, more than tripling compared to five years earlier.

The industry estimates the domestic botox market size at around 140 billion KRW annually. The market competition involves domestic companies such as Hugel and Daewoong Pharmaceutical, which are latecomers following Medytoxine, as well as imported products that received approval earlier. Medytoxine played a significant role in expanding the overall domestic market by increasing its market share through price competitiveness at launch.

Botox is a muscle contraction injection using the toxic substance botulinum toxin, a product name developed by Allergan in the United States. Initially used for therapeutic purposes such as strabismus treatment and eyelid spasms, it has become widely used for cosmetic purposes like wrinkle improvement. It is steadily growing not only in the domestic market but also overseas, with an estimated annual market size of 5 billion USD (approximately 6 trillion KRW).

This product approval cancellation is limited to the domestic market, but since Medytoxine was pursuing entry into major markets such as the United States and China, there is interest in how regulatory authorities in each country will respond to this measure. As of 10:55 AM on the 18th, Medytoxine’s stock price was 127,500 KRW, down 15% from the previous day.

MFDS: "Strict Punishment for Document Manipulation... System Improvements"

The decisive factor behind the MFDS’s approval cancellation was document manipulation. The use of strong expressions such as "deceiving regulatory authorities" and "unethical behavior deviating from quality management principles" is notable. According to the MFDS, the company manipulated documents to make it appear as if they used approved raw materials during Medytoxine production, despite using unapproved raw materials, and falsified potency test results to appear compliant even when they were out of standard.

Manipulated documents were submitted to the MFDS to obtain national batch release approval. Investigations revealed that from 2012 to 2015, the company repeatedly changed raw materials and falsified product test reports. These facts came to light following a whistleblower’s report. The whistleblower suggested that the diverted raw materials might have been used elsewhere, but this has not been clearly established in the prosecution’s investigation. The prosecution indicted the company on charges of producing with unapproved raw materials and document manipulation.

The MFDS stated, "Companies that distribute nonconforming products through document manipulation cannot be trusted," and added, "Falsification and manipulation seriously affect public health and welfare and fundamentally damage the international credibility of the domestic pharmaceutical industry."

The approval system will also be supplemented. Management guidelines will be prepared and distributed to enable tracking of change histories such as creation, modification, deletion, and addition of data to prevent false entries and manipulation in manufacturing and quality control documents.

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