The government had planned to phase out “consigned bioequivalence test system,” which allows incompetent drugmakers to sell generic drugs by relying on another company to conduct bioequivalence tests.
The tentative decision came after the controversy over Chinese-made valsartan recall due to carcinogen risk in 2018.
However, the Regulatory Reform Committee, chaired by Prime Minister Chung Sye-Kyun, advised the government to withdraw the plan, as a majority of the panelists voted against the idea, allowing the industry to go ahead with the practice.
Industry sources said the regulatory reform committee on April 10 reviewed the Ministry of Food and Drug Safety’s plan to revise regulations on drug licensing, notification and review regulations. The revision plan aimed to adopt a “1+3” program in consigned bioequivalence tests, limiting the participating generic drugmakers to one original manufacturer and three consigned makers.
The committee members discussed the issue after listening to the pros and cons of the stakeholders and opinions of the food and drug safety ministry. During the discussion, eight out of 13 members reportedly expressed negative views on the regulations of consigned bioequivalent tests.
The panelists who opposed the regulation plan said it would be difficult to expect its meaningful effect and that the causal relationship between the revision plan and enhanced drug safety was not clear. They also said the latest plan was no different from the regulation on the consignment bioequivalence test system abolished in 2010.
On the other hand, those who supported the regulation said the regulation would prompt innovation in the pharmaceutical industry and push drug companies to focus on their drug manufacturing roles rather than merely being wholesalers.
Under the majority rule, the regulatory reform committee recommended that the government should withdraw its plan to regulate consigned bioequivalence tests.
"The proposed regulation is not considered as an effective means to achieve the goal of introducing the regulation, and restricting the market entry of pharmaceutical companies also has little effect on improving drug quality and safety and promoting R&D," the committee said. "There is no reason to re-introduce a regulation similar to the one abolished in 2010. So, we recommend withdrawing the plan.”
As the committee’s decision comes at the final stage before implementing a revised rule, the food and drug safety ministry’s proposal for the “1+3” consigned bioequivalence test system will be scrapped.
The ministry said mushrooming of generic copies will push drugmakers to use cheap raw materials to cut costs. The valsartan debacle resulted from such low-quality medicines that contained low-priced Chinese-made ingredients, it said. The ministry also emphasized that the planned regulation had considered the characteristics of the generic drug market.
However, the regulatory reform committee said limiting consigned bioequivalence tests would not improve drug quality significantly.
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