Korea to tighten grip on copy drug approval

2019.11.25 13:58:09 | 2019.11.25 13:58:34

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South Korean health authorities will tighten approval criteria to prevent the overflow of generic drugs in the pharmaceutical market.

Under a planned revised procedure, the Ministry of Health and Welfare said on Sunday, a pharmaceutical company will be required to submit evidence of Good Manufacturing Practice (GMP) compliance of a third-party plant fully commissioned to produce a copy drug. The revision will also require companies to submit bioequivalence test results for all prescription medicines regardless of drug formulations.

A bioequivalence test is an in vivo study to verify the statistical equivalence in bioavailability between two drug products with the same active ingredient.

The announcement comes after the ministry’s decision in February to phase out a joint and commissioned bioequivalence test system where multiple pharmaceutical firms can chip in to commission such tests, allowing commissioned manufacturers to produce generics without bioequivalence tests for products with the same active ingredient.

But this system has been blamed for the creation of too many generics, which can cause a possible management problem in case of recall or safety measures, which was seen after the detection of a carcinogen in valsartan and ranitidine generics that affect more than 300 products this year.

For the revision, the ministry will receive industry feedback by Jan. 20 before implementing a promulgation procedure.

By Chung Seul-gi and Minu Kim

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