MFDS Revises 'Conditional Approval System for Clinical Use'

[Photo by the Ministry of Food and Drug Safety website] Ministry of Food and Drug Safety

[Asia Economy Reporter Chunhee Lee] The Ministry of Food and Drug Safety announced on the 4th that it will revise the "Guidelines for Approval and Management of Pharmaceuticals with Approval Conditions" to enhance the transparency and predictability of the "Conditional Approval System for Clinical Trials," which grants approval on the condition of submitting clinical trial results.

The conditional approval system for clinical trials is a system that grants approval on the condition of submitting Phase 3 clinical trial results after marketing, in order to provide treatment opportunities to patients with life-threatening diseases such as AIDS and cancer.

The revised guidelines specifically clarify the targets for conditional approval. These include pharmaceuticals used for life-threatening or severe critical illnesses, which encompass rare diseases under the "Rare Disease Management Act," infectious disease pandemics, or radiation emergency situations. Additionally, the guidelines specify that the system applies to pharmaceuticals for which there are no alternative drugs or those that have significant clinical benefits compared to existing drugs.

Other provisions include ▲specifying the basis when setting deadlines for submitting clinical trial protocols ▲indicating when consultation with the Central Pharmaceutical Review Committee is necessary ▲and guidelines for recording approval conditions in the approval details when granting product approval.

In particular, since failure to comply with the granted approval conditions may result in cancellation of approval, the revision also provides detailed information on setting and extending deadlines for submitting clinical trial results.

The revised guidelines can be found on the Ministry of Food and Drug Safety’s official website → Laws/Materials → Official Guidelines for Public Officials/Guides for Civil Petitioners.