The government said it would gradually scrap the “consigned bioequivalence test system,” which allows incompetent drugmakers to sell generic drugs by relying on another company to conduct bioequivalence tests.
The authorities will limit the number of companies applying for joint bioequivalence tests to three, besides the first manufacturer of generic medicine, and entirely scrap the system three years after the revision of the related rules.
Industry watchers are paying attention to whether the government’s move will address the problem of reckless production of generic drugs.
The Ministry of Food and Drug Safety announced its draft plan to revise the generic drug approval system during a meeting between the food and drug safety minister and CEOs of the pharmaceutical industry at the Plaza Hotel in Seoul, Wednesday.
The ministry said it would adopt a “1+3” program in consigned bioequivalence tests, limiting the participating generic drugmakers to the single manufacturer and three other companies.
The “1+3” program will start one year after the revision of the related rules, and the consigned bioequivalence system will be removed completely three years afterward, the ministry said. After discontinuation of the system, one generic drugmaker should submit one bioequivalence test data.
The joint bioequivalence test system allows multiple pharmaceutical companies to conduct bioequivalence tests on a single generic medicine. Although the government banned the system from 2007 to 2011, the sunset provision allowed it to be restored in 2012.
Since 2012, the number of generic items has shot up, generating excessive competitions. In 2017, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) suggested the government limit the number of bioequivalence test subjects to four.
In particular, the massive recall of hypertension drugs using Chinese-made valsartan due to carcinogen risks in 2018 prompted social discussions on the excessive number of risk generic drugs.
The valsartan debacle led the ministry to start searching for measures to improve the generic drug approval system including joint bioequivalence tests.
The pharmaceutical industry is supporting the government’s move.
Won Hee-mok, president of KPBMA, said that it was desirable to limit excessive consigned bioequivalence tests at a New Year’s news conference “Rather than scrapping them immediately, the government should remove them gradually,” he said.
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