[2022 National Audit] "42% of Conditionally Approved Drugs Did Not Submit Clinical Trial Results"

Assemblyman Choi Jong-yoon, "Clinical Trial Progress Reports Are Also Not Properly Submitted"

[Office of Assemblyman Choi Jong-yoon]

The 'Conditional Approval System for Pharmaceuticals,' which allows sales with only the submission of a clinical trial protocol, is being poorly managed. However, the Ministry of Food and Drug Safety (MFDS), the responsible agency, is reportedly trying to expand the program rather than improve it.

According to data on conditional approval items submitted by the MFDS to Choi Jong-yoon, a member of the National Assembly's Health and Welfare Committee from the Democratic Party of Korea, 15 out of 35 approved items (42%) over the past 10 years have not submitted clinical trial results even three years after approval. Some approved items have not submitted trial results even after 10 years.

The conditional approval system, also called the 'Fast Track Approval System,' permits the sale of drugs such as anticancer agents, treatments for serious diseases, and orphan drugs on the condition that phase 3 clinical trial data are submitted within a separately designated period. It was introduced to improve treatment accessibility for patients with difficult-to-treat conditions.

The problem is that there is no deadline for submitting clinical trial result reports for conditionally approved items, leading to exploitation of this loophole. Rep. Choi explained, "If the submission of clinical trial result reports for conditionally approved drugs is delayed beyond the period set by the pharmaceutical company, the MFDS grants extensions after internal discussions and consultations," adding, "This process does not even go through the Central Pharmaceutical Review Committee, an advisory body to the MFDS."

Additionally, pharmaceutical developers of conditionally approved drugs are required to report the progress of clinical trials semiannually, but only 7 out of the 35 items submitted such progress reports. This means 80% of conditionally approved items did not report clinical trial progress.

Rep. Choi stated, "Management and supervision of the existing system are already inadequate, and if the Yoon Seok-yeol administration pushes forward the 'Global Innovative Fast Track (GIFT)' system, it will pave the way for pharmaceutical companies to exploit this system," adding, "Measures must be taken to prevent the system from being abused for purposes such as boosting pharmaceutical companies' stock prices or development, which deviates from the original intent of expanding patients' treatment opportunities."

GIFT is a system by the MFDS that encourages faster market entry by shortening the review period for innovative medical products by about 75% compared to the existing process.