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Generic drug approvals doubled amid imminent scrap of consigned bioequivalence tests
  • By Lee Hye-seon
  • Published 2019.04.11 16:00
  • Updated 2019.04.11 16:00
  • comments 0

After the Ministry of Food and Drug Safety announced that it would gradually scrap the “consigned bioequivalence test system” in February, the number of approvals for generic drugs in the first quarter almost doubled compared to a year earlier.

The system allows incompetent drugmakers to sell generic drugs by relying on another company to conduct bioequivalence tests.

According to data from the ministry, the number of approvals given to generic drugs recorded in “data-sharing documents” went up to 529 in the first quarter, 2.2 times increase from 237 in the same period last year.

The data-sharing documents prove that an original drug manufacturer shared data needed for joint bioequivalence tests with another pharmaceutical company.

Considering that generic drug approval takes much time typically, many pharmaceutical firms sought approval for copy drugs early, especially since the recall of carcinogen-containing valsartan last year pushed the government to tighten regulation on consigned bioequivalence tests.

“It seems that pharmaceutical firms applied for generic drug license in advance, as the public opinion started to push the government to regulate joint bioequivalent tests in the wake of the valsartan recall last year,” an official at the food and drug safety ministry said.

The government is expected to put to notice an amendment of the regulation to phase out the consigned bioequivalence test system as early as this week.


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