China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications

China will carry out risk-level-based pre-approval inspections on R&D and manufacturing sites involved in drug registration applications. When necessary, the inspections can extend to relevant API, excipient, packaging material manufacturers, suppliers, and contract organizations.
by Grace Wang Dec 24, 2021

On Dec. 20, China's Center for Food and Drug Inspection (CFDI) released the Work Procedures for Drug Registration Inspection (Trial) and other four detailed rules for drug inspections1.

On the same day, the Center for Drug Evaluations (CDE) rolled out the Work Procedures for Initiating Drug Inspections and Controls (Trial)2.

The regulations, all set to take effect on Jan. 1, 2022, apply to on-site inspections of drug establishments in China if the firms pertain to drug registration applications.

Overseas inspections, pre-approval or post-marketing, shall abide by the foregoing regulations and the Administrative Rules on Overseas Inspections of Drugs and Medical Devices3.

China's Drug Registration Inspections

Competent Authorities

Ÿ   Initiator: CDE;

Ÿ   Inspection organizer and implementer: CFDI.



Ÿ     To verify the authenticity and consistency of data in drug registration applications;

Ÿ     To evaluate if the drug is qualified for commercial manufacture;

Ÿ     To evaluate the regulatory compliance of drug R&D;

Ÿ     To audit R&D data integrity, etc.

Sites for Inspection

Ÿ   Drug R&D sites;

Ÿ   Drug manufacturing sites;

Ÿ   Active pharmaceutical ingredient (API), excipient, packaging material manufacturers, suppliers, and contract organizations (if necessary).

Categories of Inspection


Ÿ     Chemistry, manufacturing and controls (CMC);

Ÿ     Toxicology;

Ÿ     Clinical Trial.


CDE will decide whether to carry out pre-approval inspections according to risk levels for the three categories of drug registration applications:

Grace Wang
ChemLinked Regulatory Analyst
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