China CDE director vows more support for drug review & approval in the coming years.

The director of China’s Center for Drug Evaluation (CDE) has delivered a speech on Improving the Efficiency and Quality of Drug Review & Approval at the 2022 DIA China Annual Conference, with a retrospective summary of the last 5 years’ work and an outlook for the future.

Substantial Growth in the past 5 year, both the received drug registration applications and the completed registration cases have seen consecutive increase. From 2017 to 2021, the number of drug applications have increased from 4839 to 11658, an average annual increase by 24.59%. The number of completed registration applications significantly increased by 14.12% from 7124 to 12083 applications, according to Kong Fanfu, the director of CDE.

CDE director also noted that the 4 “accelerated pathways” for drug approvals include:

  1. Breakthrough therapy drugs
  2. Conditional approval
  3. Priority review & approval
  4. Special review & approval

These 4 pathways have contributed significantly to the growth in speed of application. The time limit for drug registration applications via the accelerated pathways has been expedited from 200 days to 130 days now.

More support in future. To go beyond the achievement, Mr. Kong has promised that the CDE will take concrete measures in multiple aspects as summarized below:

To provide strong technical support for the R&D as well as review & approval of drugs, CDE will make 300 new or revised technical guidelines within 2021-2025. It is expected that by 2025, the total number of technical guidelines for drugs will surpass 600.

As the zero-COVID policy retreats and more support taps into the review & approval system, there is enough reason to believe that China’s drug market will see a steady and rosy picture in the near future.

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