Korea to Start Random Bioequivalence Testing for Marketed Drugs

On April 14, 2014, the Korean Ministry of Food and Drug Safety (MFDS) announced that it is planning to test random drug samples of products currently on the market, starting in June 2014. Both generic drugs and original drugs will be tested, as well as various lots of the same pharmaceutical products. The goal of this testing program is to improve the quality of generic drugs on the market in Korea. 

According to the MFDS, the committee for bioequivalence testing first met in late April 2014 to discuss plans for implementing this testing program. The committee consists of doctors, pharmacists, scholars and government officials. The committee is also discussing various plans for what to do if variability is found in the samples being tested.

The MFDS also recognizes that, beyond equivalence testing, there are more complex underlying variables. As such, the bioequivalence testing will likely go beyond simply verifying the equivalence of two pharmaceutical products. However, the exact details of the testing plans or what system will be in place to address any poor test results have yet to be released by the MFDS.