(Yicai) Aug. 29 -- China intends to make it more difficult for novel medicines to enter the market via a streamlined process before finishing clinical trials due to unmet medical demand.

The National Medical Products Administration plans to raise the threshold as it will no longer automatically give the green light to clinical trials of medicines to get emergency use authorization when a similar drug has already been granted conditional approval in order to reduce repetitive research and development, the regulator said in a draft released recently.

Conditional marketing approval is designed for medicines that treat serious life-threatening diseases with no effective treatment available. It is also a way to fast-track the registration process for products that are urgently needed by the public such as Covid-19 drugs before the clinical trials are ready. 

Although the policy shift is somewhat reasonable, medicines that have gained the conditional permit may not be the most efficient, which could be a loss for the patients, Xiao Shen, chief medical officer of 3D Medicines, said to Yicai. Subsequent medicines could still enter the process as normal but it will take longer and patients have no alternatives during this time, Xiao added.

The policy would also change the procedure for firms that have successfully obtained conditional permits as the draft would require them to submit the complete clinical trial results in four years or risk losing their marketing permits whereas right now, pharmaceutical companies can gain a registration certificate immediately.

The move means that follow-up clinical trials will become necessary for new drugs that have been given the emergency use status or otherwise they will eventually be removed from the market, Xiao explained. 

Conditional release was a major gateway for medicines to enter the market in China in 2021 as almost 19 percent of all new registration applications that year were given this type of authorization, based on official data. 

Editors: Tang Shihua, Emmi Laine