he regulatory reform over the last two years has started to produce significant outcomes. According to analyses conducted by GBI Health, in 2017 the China Food and Drug Administration (CFDA) approved a record number of imported new drugs (new chemical entities), and the number of innovative new drug regulatory applications, including clinical trial applications and marketing applications, was also the highest in five years.

The CFDA approved 34 imported innovative chemical drugs and five imported novel biologic products in 2017 (Table). Top three therapeutic areas were oncology, Type 2 diabetes, and hepatitis C. Among the 39 approvals, 24 (or 62%) were granted “priority review” status under the regulator reform initiative.

“Drug lag” has long been recognized as a major issue in China; the CFDA has made accelerating drug approval for unmet medical needs a reform priority. The median drug lag of the 2017 new chemical drug approvals, as compared with their respective first approval outside China, was around 4.3 years. While the lag is still notable, the large number of approvals last year was viewed as the CFDA’s effort to reduce the drug lag that had accumulated throughout the past years prior to the reform. It can be expected that the lag will be further reduced, as the result of CFDA’s policy changes favoring global clinical trials and more efficient review and approval processes.

On the other hand, approval of biologic products remains challenging. The drug lag for these products was much longer, with a median of eight years for five approvals in 2017.

New Chemical Drugs and Novel Biologic Products Approved by CFDA in 2017

On the domestic side, it was notable that in October 2017, the CFDA approved a recombinant vaccine against Ebola virus jointly developed by a Chinese academic research institution and a local biotech company.
As a way to encourage discovery and development of truly innovative medicines, the Chinese Authorities revised the definition of a “new drug” as a drug not approved both inside and outside China. The “new drug” category offers numerous incentives in policy support and regulatory review. However, no new chemical drugs under the newly revised “new drug” definition from Chinese pharma companies was approved in 2017.

There was a surge of clinical trial applications of innovative drugs filed in 2017: 104 clinical trial applications were filed for innovative chemical drugs, almost as many applications as in 2015 and 2016 combined. The number of clinical trial applications for novel biologics was 60—more than double compared with 2016 filings. This surge in applications indicates that innovative drug R&D in China is taking on a momentum of rapid development.

On March 13, 2018, a plan to restructure the central government was revealed at the first session of the 13th People’s Congress. According to the plan, the CFDA will be reorganized as State Drug Administration (SDA) and become part of a newly-created super government agency of market supervision administration. As its name indicates, the future SDA will primarily be responsible for drugs. At the time of writing this report, it is too early to predict the specific changes resulting from the reorganization. However, it is widely believed that the direction and trend of the regulatory reform will continue to move forward.