China amends drug review and approval system

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The Central Committee of the Communist Party of China and the State Council have announced Monday new plans to reform the review and approval system for drugs and medical devices.

A slate of suggested amendments to relevant regulatory rules seeks to fulfill the urgent need of advanced medicines and to enhance the innovation ability of the country’s pharmaceutical industry.

China Food and Drug Administration (CFDA) held press conference on Monday to announce the reform. / China.com.cn Photo

To address clinical medication shortages, a new clinical trial management system will replace the current qualification system. More social forces are also encouraged to participate in clinical trials and implied license will be given to certain medical institutions, which will be used to apply for an express permission before carrying out the trials.

China will further speed up and optimize the review and approval process, especially for innovative products. Drugs that can be used to treat rare diseases as well as those drugs with significant clinical advantages will be reviewed as priority and given conditional approval.

Special drugs could be put into use with special approval before all clinical studies are completed. /VCG Photo

In other words, drugs could be put into use with special prior approval before all clinical studies are completed, once they are proved to be effective in curing life-threatening diseases in the early or middle phase of clinical trials.

The document provides legal guarantee for drug invention as well. Besides, new administrative measures will also soon be applied to pharmaceutical management, such as a new marketing system separating drug marketing from drug production to ensure drug safety and medical research.

Wu Zhen, deputy director of CFDA./ China.com.cn

For foreign pharmaceutical firms, a fast-track channel for certain overseas drugs to enter the Chinese market has been established, which gives consumers more choices. Some medicines for rare diseases that are already on the overseas market will be given conditional approval, said Wu Zhen, deputy director of China Food and Drug Administration.

“Clinical trial data collected overseas were not approved in the past, but now we are beginning to accept it, under certain circumstances. Foreign data corresponding with China's drug registration requirements can also be used,” he added.