Clinical Trial Medicines for Incurable Disease Patients in Korea

The Korean Cabinet recently passed a bill to allow the use of clinical trial drugs for patients suffering from serious illnesses having no alternative treatment options. This bill is a revision to the current Pharmaceutical Affairs Law and was approved August 28, 2007.

After approval from the Korea Food and Drug Administration (KFDA), patients with serious diseases will have access to drugs still undergoing clinical trials and that have not yet been approved by the KFDA. The government hopes to maximize treatment options for patients suffering from AIDS or the last-stages of cancer.

This process would require manufacturers to register the production specifics. In addition, the government would review the safety and potency of new drugs before product registration.

In addition, the government also passed a bill to reduce administrative barriers for treatment for patients with diseases caused by defoliants.