Bioequivalent tests will be managed in the same level of control with clinical trials

This October, the process of acquiring approval of bioequivalent test will be dealt the same as the one of acquiring approval of clinical trial.

The Ministry of Food and Drug Safety(MFDS) asked the pharmaceutical industry to pay attention as the ‘Regulations for Drug Clinical Trial Approval Acquisition’ would be enforced with new rules about taking the same approval process for bioequivalent t...