China Implements GMP Appendix for Investigational Products Used in Clinical Trials

by Grace Wang Jul 01, 2022

On July 1, 2022, the Appendix to Good Manufacturing Practice (GMP) for Pharmaceuticals: Investigational Products Used in Clinical Trials comes into effect. The Appendix is a supporting document for China's pharmaceutical GMP, which was revised in 2010 and has been effective since 2011.1

The Appendix applies to

  1. the preparation of investigational products used in clinical trials, including the investigational drugs being tested or the comparator drugs/placebos used as a reference2; the clinical trials aim for China's marketing authorization of the investigational drugs.

  2. changes to packaging/labels of marketed drugs that are used as comparator drugs or investigational drugs3;

  3. adding correctants to comparator drugs for blinded experiments.

* The Appendix is also a reference for active pharmaceutical ingredients (API) used in investigational products.

* If early-phase clinical trials are carried out for adding a new indication to a marketed drug, without changes to the dosage form and manufacturing process, then the manufacturing quality control should comply with GMP for marketed pharmaceuticals instead of this Appendix.

The GMP for investigational drugs focuses on the following aspects:

  • Quality management

  • Personnel

  • Factories, facilities, and equipment

  • Management of materials

  • Management of documents

  • Management of drug preparations

  • Quality control

  • Product release

  • Delivery and transportation

  • Complaint and recall

  • Retrieval and destruction

To find out specific GMP requirements for investigational products, please read our previous news report "China Specifies GMP Regulations on Investigational Products Used in Clinical Trials". You're also welcome to consult BaiPharm directly.

Grace Wang
ChemLinked Regulatory Analyst & Editor
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