Treatments for life-threatening serious and rare diseases are being granted conditional approval from July 21st this year.

However, to inform the public of the conditions, items for which data on confirmatory clinical trials were not submitted should be specified in the label’s indication, and the clinical trial status of the subject drugs needs to be reported to the Minister of Food and Drug Safety by March 31 each year.

At a trade journal correspondent briefing that was held on the 30th, Soo-Jeong Lee, Director for Approval Management of the Ministry of Food and Drug Safety, said, “With the amendment of the Pharmaceutical Affairs Act and the amendment of the Regulation on Safety of Medi