The Chinese Government set new rules to speed up drug approvals

Print 11 October 2017
GMP News

China will encourage innovation in drugs and medical equipment by expanding the reform of review and approval system in the medical sector, according to a guideline recently issued by the General Office of the Communist Party of China Central Committee and the General Office of the State Council.

The most significant change in the new policy is that data obtained from overseas multi-center clinical trials can be used directly for the innovative drug and medical device application process in China. As a result, China’s innovative drug approval, usually lasting as long as eight years partly due to the requirement for additional clinical trial conducted in the country for all overseas innovative drugs, could be significantly shortened.

According to the guideline, management of clinical trials will be reformed through record-filing management of clinical trial institutes, encouraging social forces to invest in clinical trial institutes, and supporting medical organizations, research institutes and colleges to conduct clinical trials.

Clinical trials should conform to ethical standards to protect the subjects’ safety, health, rights and interests, said the guideline. Each clinical trial institute should set up an ethics committee to review its clinical trial programs, examine the subjects’ qualifications and oversee the process of the trials.

The review and approval for urgently needed drugs and medical equipment should become faster, including those that can be used to treat severe life-threatening diseases lacking effective treatment or are urgently needed for public health.

Registration management and technical review systems in line with the characteristics of traditional Chinese medicines (TCM) will be established to support the inheritance and innovation of TCM.

Measures will be introduced to promote drug innovation, including setting up a catalog of marketed drugs, building a system linking the review and approval of drugs with their patents, and improving the protection of drug trial data.

Drug and medical equipment manufacturers are encouraged to increase research and development (R&D) input, strengthen R&D on new products and continue studies on marketed products to improve their production quality.

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