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Government to overhaul generic drug approval system
  • By Lee Hye-seon
  • Published 2018.11.19 11:59
  • Updated 2018.11.19 11:59
  • comments 0

The Ministry of Food and Drug Safety plans to fix up problems caused by the reckless production of generic medicines, devising up measures to overhaul the drug approval system within this year.

Kim Sang-bong, director of the ministry’s Pharmaceutical Policy Division, said the renewing of the approval system would involve three aspects – R&D, exports, and distribution market order.

He said the government planned to revise “the consigned bioequivalence test system” or “the joint bioequivalence test system,” which allows incapable drugmakers to lean on another company to conduct bioequivalence tests of generic drugs and sell them.

“We are also considering requiring data that used to be exempt during the approval process,” Kim told Korea Biomedical Review on Thursday.

Earlier in 2016 and 2017, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) repeatedly asked the government to improve the consigned bioequivalence test system to curb excessive output of generic copies.

This year, the massive recall of hypertension drugs containing Chinese-made valsartan, which had a possible carcinogen, ignited social calls to regulate generic medicines.

Kim also said that the government was reviewing all the requirements for approval that had been exempted or omitted.

“The ministry is reviewing quality control data, too. We are seeing whether it is permissible to authorize a drug by looking at a piece of paper that copied from a pharmacopeia,” he said. “Also, we’re reviewing whether it was right to approve without quality control data, even though we had the standards.”

The upcoming improvements will also address the issues coming from exported pharmaceutical goods.

Korea’s status in the pharmaceutical sector rose as the nation joined the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

However, a simplified local drug approval system made Korean drugmakers have trouble when shipping their goods.

“In Vietnam, the authorities usually demand Korean companies’ submission of quality check data, but the simplified domestic approval system becomes a problem. They have no problem in the local market, but some foreign countries do not accept their simplified data,” Kim said. “When makers of generic drugs or incrementally modified drugs try to sell drugs overseas, they should see if there was any problem from the local drug approval system.”

“Although having generic drugs are not a problem, everyone else except for generic drug makers was pointing out that the current generic drug approval system had a problem,” Kim said. “The industry already knows what the agenda is. We’ve reached a critical point.”

The food and drug safety ministry was focusing on how to make the system balanced with those in other countries so that companies could perform better, according to Kim.

“Basically, it is the government's job to create a balanced ecosystem, and it is up to pharmaceutical companies to adapt to this system. Domestic companies are competitive enough to do so,” Kim said. “The issue is where they will focus their capabilities – R&D, distribution order, or exports.”


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