(Yicai) April 27 -- China’s main drug regulator has issued new rules requiring innovative drugs granted conditional marketing approval to complete confirmatory clinical studies within four years or risk being withdrawn from the market.

The National Medical Products Administration's new policy, which took effect on April 24, means drugmakers must complete the required studies within four years of conditional approval to obtain regular approval. Those who fail to do so may, in principle, apply for only one extension, while the validity period of the drug registration certificate will not be extended along with the study deadline.

If the studies are not completed by the deadline and no extension is granted, or if they remain unfinished after an extension, the drug’s registration certificate will be revoked or its approved indications reduced, according to the new rules.

The policy creates institutional incentives and constraints for drug marketing authorization holders to complete confirmatory studies quickly, especially because the validity period of the drug registration certificate will not be extended, a person engaged in drug clinical research and development told Yicai.

The new rules will also close a policy loophole that has allowed conditionally approved drugs to remain for long periods in a stage where their efficacy has not been fully verified, the person noted.

Crackdown on “Piggybacking" Innovation

In addition, homogenized “piggybacking" innovation will be curbed. Under the new rules, if a drug with the same mechanism, target, and indication has already obtained regular marketing approval, the conditional approval channel for similar drugs under development or review will be closed.

The new rules “strictly control the review standards for conditional approval and prevent piggybacking behaviors,” an expert close to the Center for Drug Evaluation of the NMPA told Yicai.

Background: Gaps in Previous Rules

The Measures for the Administration of Drug Registration, revised in 2020, formally established China’s conditional approval procedure for the first time. The system allows innovative drugs and improved new drugs in urgent clinical need to be approved based on early clinical trial data, significantly shortening the pre-market review and trial period and helping meet patients’ medical needs sooner.

The measures state that conditionally approved drugs must later complete confirmatory studies. But because no time limit had been set for such studies, some drugmakers lacked urgency after their products entered the market.

Since China’s first conditionally approved new drug was cleared in 2020, about 140 drugs covering nearly 200 indications have entered the market through this pathway. Only about 30 indications have completed confirmatory studies and obtained regular approval, while most drugs or indications have remained under conditional approval for a long time after launch.

Editors: Tang Shihua, Emmi Laine