Expedited Programs for Drug Registration in China

China currently follows four programs for accelerating the review and approval of new drug applications (NDA) that meet the corresponding criteria.

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	Work Process for Breakthrough Therapy Designation of Drugs (Trial); Work Process for Conditional Approval of Drugs (Trial); Work Process for Priority Review of Drugs (Trial).
Nov. 19, 2020	Nov. 19, 2020	Technical Guidance for Drugs Going to the Market With Conditional Approval (Trial)

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