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Korea Pharmaceutical Bio Association is a member company Binex (053030)In the case of voluntary change in the manufacturing process of pharmaceuticals, the company will investigate the facts and refer to the ethics committee. It is going to be carried out separately from the government’s disposition, and with this as an opportunity, we plan to accelerate the prevention of the mess of generic drugs (replicas).
The association issued a statement on the 11th and said, “The Binex case is an unacceptable crime.” The association emphasized that “we will take decisive measures, such as a separate investigation by the Ministry of Food and Drug Safety, and referral to the ethics committee to Binex.”
The association pledged, “With this incident, we will check the overall status of the consignment production process and quality control of member companies.”
The association’s policy is to prevent generics from being scattered so that similar events do not recur. In order to obtain approval from a generic drug, a pharmaceutical company must go through a livelihood proving that it has the same efficacy and safety as the original drug. Currently, in Korea, several pharmaceutical companies can jointly pay a fee to entrust the live test, and there is no limit to the number of participating pharmaceutical companies, which is considered one of the causes of the generic mess.
The Ministry of Food and Drug Safety decided to step through a step-by-step abolition procedure after implementing a ‘1+3’ measure limiting the number of co-living items to one original manufacturer and three consignment manufacturers to prevent generics from being scattered. The association said, “We will cooperate with the National Assembly for the rapid institutionalization of ‘1+3 restriction’ of commissioned and co-living (biological equivalence test).”
The association added, “I hope that the exceptional offenses of certain companies will not turn into a trust problem for our industry as a whole.”
Prior to this, the Ministry of Food and Drug Safety confirmed that Binex manufactured medicines differently from the matters that were approved or reported, and took measures to suspend and collect sales of 6 products from Binex and 32 products from 24 companies that were commissioned. The day before, the Ministry of Food and Drug Safety initiated a seizure and search of Binex’s Busan factory to confirm the illegal matters.
/ Reporter Joo-won Lee [email protected]
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