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 will all take effect on Jan. 1, 2022. They apply to on-site inspections of R&D and manufacturing sites that are related to drug registration in China.

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:

  1. marketing authorization applications (NDA & ANDA);

  2. supplemental applications for major changes to drug formulation, manufacturing techniques, or production lot size, or for the addition of new clinical trial data;

  3. Other registration applications that require pre-approval inspections.

The risk levels are determined according to drug varieties and regulatory compliance of the drug's researchers and manufacturers.

High-risk applications include marketing authorization applications for innovative/improved chemical drugs and biological products. The proposed drug products in the high-risk applications will definitely receive pre-approval inspections.

The pre-approval inspections are also mandatory for APIs of Class 1 innovative chemical drugs and Class 2.1 improved chemical drugs. Pharmaceutical excipients and packaging materials will possibly receive extended inspections.

As for applications of lower risk levels, only a proportion of them will receive pre-approval inspections.

RELATED: China Chemical Drug Registration Classification

China's pre-approval inspections is going to be more precise with detailed regulations targeting different drug registration applications. The inspections are no less stringent—they go deep into the raw data and the very places where drugs are developed and manufactured.

Therefore, drug makers need to ensure regulatory compliance and collect authentic, sufficient and reliable data to prepare for pre-approval inspections.

BaiPharm is willing to help you in the efforts to get a successful outcome in China's drug inspections. We are a pharmaceutical regulatory consulting service provider with multiple strengths:

  • Experienced in preparing ANDA, CTA/IND, BLA, BE studies, MRCTs, NDA documentation; filing DMFs for APIs, excipients, and packaging materials.

  • Having a global network of offices, business representatives and experts across China, Japan, South Korea, the US, and Europe to offer 24-hour services to clients.

  • Providing multi-language translation services covering Chinese, English, Korean, Japanese, German, and Italian.

Contact BaiPharm and let us offer our expertise to your projects.

Grace Wang
ChemLinked Regulatory Analyst
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