Korea refines rules for safe, swift approval of biopharmaceuticals

New rules being considered by South Korea’s Ministry of Food and Drug Safety (MFDS) would make it easier to investigate the safety of high-tech cell therapies and genetic treatments, as well as other biopharmaceutical products, before they are approved.

The new screening procedures involve the use of systematized data according to the formation of Common Technical Documents (CTD), a standardized form of data required for the application for drug approval by the ICH. It consists of quality evaluation, non-clinical studies, and clinical trial data.

The new regulations mandate a step-by-step preliminary screening of the drugs, but also provide a pathway to rapid approval of some needed urgently by patients. The new screening processes are expected to increase safety but also expedite drug development.