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Original title: Part of Medto botulinum toxin whose license has been revoked in South Korea flows to China, only 3 brands have been approved
Beijing News (Reporter Wang Kara) According to CCTV Financial News, the Korean Food and Drug Safety Agency revoked the license of Innotox, a type A botulinum toxin produced by the South Korean company Medto Company, to counterfeit experimental materials, as of 26 December. January. the company’s third botulinum toxin product whose license has been revoked. Part of the product has been imported into the country through the purchasing agent and has been used by some beauty institutions.Chinese medicineLiu Jingtao, vice president and general secretary of the Aesthetic Medical Industry Branch of the Press Information Association, recalled that currently only three national brands of botulinum toxin products have been approved, so beware of illegal products on the market.
Many botulinum toxin products under Mido have been revoked
The Korean Food and Drug Safety Agency stated that, according to prosecutors’ investigation, the company falsified experimental materials in the application and license exchange process for Innotox drugs, in violation of relevant laws. On December 22 last year, the Korean Food and Drug Safety Agency ordered Medto to suspend the production and sale of related products, and required companies to recall or destroy the products in circulation.
Mido is the first company in Korea to obtain a Botox license, and its market share in Korea has reached 36%, ranking first for ten consecutive years. According to the advertising content of the company’s official website in China, the company’s market value in 2019 was 1,732.9 billion won and its turnover was 205.9 billion won. Their products are exported to almost 60 countries around the world and they hope to enter the European and American markets in the near future. The company has wholly-owned joint ventures or subsidiaries in China, Taiwan, Hong Kong, Thailand, and Japan, and has established an office in Maryland, USA. In addition to botulinum toxin type A products, the company also has products such as hyaluronic acid fillers and medical equipment.
Besides Innotox, Meidero also has two other Botox brands, Meditoxin and Coretox. According to CCTV Finance, the licenses for these two products have also been revoked. A reporter from the Beijing News found on the official website of Mido China that these three brands have a total of 8 products with different specifications.
A reporter for the Beijing News discovered that the company was in bad shape. According to a CCTV Finance report from July 2019, in May 2019 the sterile production workshop of Mido was detected with excess bacteria. In addition, the company also sent clinical samples to the plastic surgery hospital between 2003 and 2005 without obtaining official approval from the Korean Food and Drug Safety Agency. The sample size can be 450 operations. South Korea’s JTBC television station also revealed that the company’s product test report data was falsified and products that were deemed unqualified in quality were replaced with production numbers and continued to be sold. Additionally, batches of facelift needles produced between 2015 and 2016 were not sterilized. Samples used for clinical trials in China in 2016 may come from the same production line and face the same threat.
In July 2019, the Korean Food and Drug Safety Agency determined that the company’s three batches of botulinum toxin for export were of unqualified quality and were ordered to be withdrawn from the market and destroyed. These products are mainly sold to Thailand, Japan, Brazil and other countries The scale of the products involved has a contract of 20 million yuan. At the time, the Korean Food and Drug Safety Agency stated that it would further investigate other batches of products produced by the company before determining the level of administrative penalty.
On April 17, 2020, the Korea Food and Drug Safety Department ordered Medto to suspend the production and sale of botulinum toxin type A Meditoxin (Neurono) 50u, 100u and 150u indefinitely, and impose a contract on the company. for about 102 ten thousand yuan. As of June 25, 2020, the licenses of the three above specifications will be revoked and the company will have to recall and destroy related products because the company used an unapproved stock solution in the production process and obtained the circulation license through fraud. material, which violated the relevant legal regulations.
Only three national brands have been approved and the rest are imported through illegal channels
To formally enter the Chinese market, in 2016, Medto filed an application with the China Drug Administration, which has so far not been approved. However, South Korean television station JTBC noted that the amount of meditoxin exported to China is about 50% of South Korea’s total botulinum toxin exports. According to the data from the Korean Customs Service, it can be inferred that the total amount of meditoxin exports to China in 2019 will exceed 40 million US dollars.
In our country, botulinum toxin type A has a very strict management. The “Notice on Strengthening the Administration of Botulinum Toxin Type A for Injection” issued in 2016 requires companies that produce (import) botulinum toxin for injection to designate a pharmaceutical wholesale company with the qualification to purchase and operate medical toxic drugs such as your injection A commercial company that uses botulinum toxin type A, and the designated commercial company sells its products directly to medical institutions or medical beauty institutions that have obtained the “Medical Institution Practice License”. Non-designated drug dealers may not buy or sell botulinum toxin type A for injection; the production and operation companies will not sell botulinum toxin type A for injection to units that have not obtained the “Exercise License from the medical institution”; Drug retailers will not sell Type A Botulinum Toxin for Injection Type Botulinum Toxin.
The notice also recalled that departments at all levels should strengthen the supervision and management of the production and operation of botulinum toxin for injection, prevent it from flowing to illegal commercial beauty institutions through legal channels, and prevent counterfeit drugs from entering legal channels. The circulation link of botulinum toxin type A for injection should be inspected. Violations of laws and regulations that are discovered during the control and inspection will be severely punished in accordance with the law; those suspected of crimes will be transferred without delay to the public security organs.
Liu Jingtao, vice president and general secretary of the Aesthetic Medical Industry Branch of the China Medical News Information Association, recalled that my country has only approved three botulinum toxins type A, one of which is a national Hengli brand, and two are imported brands. Botox and Dysport. Those seeking beauty should go to a formal beauty medical institution. Common beauty institutions are not qualified to conduct botulinum toxin injection business. At the same time, you should choose a regular plastic surgeon and, when choosing a botulinum toxin product, identify whether it is from the above three legally approved products, and not use products that have been imported into the country through illegal channels.
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