Expedited Programs for Drug Registration in China
Nov. 19th, 2021
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- breakthrough therapy designation (BTD);
- conditional approval (CA);
- priority review (PR);
- special approval (SA).
If an NDA enter any of the above programs, NMPA and its professional institutions will offer policy and technology support to the applicant. The support includes necessary technical guidance, communication with the applicant, preferential allocation of resources, and shortening the review time.
1. Regulatory Updates on Drug Review and Approval in China
To take the lead in the ever-changing Chinese market, international pharmaceutical companies need to keep abreast of the regulatory updates of marketing authorization procedures:
Laws, Regulations and Policies Involving Requirements for Drug Review and Approval in China | ||
Issuance/Revision | Enforcement | Law/regulation/policy |
Oct. 8, 2017 | Oct. 8, 2017 | Opinions on Deepening the Reform of Review and Approval System to Encourage Innovation in Drugs and Medical Devices |
Aug. 26, 2019 | Dec. 1, 2019 | Drug Administration Law |
Mar. 2, 2019 | Mar. 2, 2019 | Provisions on Implementing the Drug Administration Law |
Jan. 15, 2020 | July 1, 2020 | Administrative Measures for Drug Registration |
July 8, 2020 | July 8, 2020 |
|
Nov. 19, 2020 | Nov. 19, 2020 | Technical Guidance for Drugs Going to the Market With Conditional Approval (Trial) |