Korea Cracks Down on Local Clinical Trials

Starting in October 2018, the Korean Ministry of Food and Drug Safety (MFDS) will implement stronger controls on clinical trials done in Korea. Going forward, medical institutions will need to provide more information on possible side effects of a clinical trial. In addition, institutions will need to provide patients with more information on each trial and the name of the sponsor. Penalties have been made tougher for not reporting side effects. Falsifying records may result in losing licenses for conducting clinical trials, cancellation of business, fines, and possibly prison.

Korea ranked as the 6th largest country for drug clinical trials last year, and the Korean government has strongly supported new drug development over the last 5-10 years. Between 2012 and 2017, 82 Korean people died and over 1,100 people were hospitalized.