To promote the adjustment of industrial structure and technological innovation in the drug and medical device products sector, the Communist Party of China’s Central Committee and the State Council jointly released a guideline on the reform of the review and approval system, which came into effect on October 8, 2017.

The guideline lays out several primary objectives. These include overhauling the management of clinical trials, accelerating the drug and medical device approval process, promoting drug innovation and the development of generic drugs, enhancing the administration of drug and medical devices throughout the product life cycles, and improving technical review infrastructure for greater transparency and oversight.

Notably, the guideline stipulates that qualified overseas clinical trial data can now be used in the drug and medical device products registration and approval process. In the face of a grave threat to public health, drug and medical device registration approvals shall be fast-tracked. In addition, a rare disease catalogue will be set up and new products that can treat these rare diseases could be eligible for reduced trials.

The guideline was based on the China Food and Drug Administration (CFDA)’s policy proposal published in May 2017. Following the release of this guideline, the CFDA released a decision to adjust the registration of imported drugs, explicitly permitting phase I clinical trials to be carried out in China. Previous requirements that imported drugs used in the clinical trials must be registered abroad or have been used in the phase II or III trials have been scrapped.

With more measures on drug and medical device products registration reform coming out, such as the new Medical Device Classification Catalogue, China’s life science industry is expected to grow more competitive and dynamic in the near future.