China clinical trials for drugs GMP have been strengthened. The NMPA has supplemented the Good Manufacturing Practice (GMP) for Pharmaceutical Products (revised in 2010) with an Appendix on "GMP for Drugs for Clinical Trial".
The Appendix (No.43-2022) was published on May 27, 2022 and will be implemented on July 1, 2022. It is the 13th appendix to the GMP for Pharmaceutical Products (2010 revision).
This Appendix clarifies that the preparation and quality control of drugs for use in clinical trials should:
- follow the basic principles and data reliability requirements of Good Manufacturing Practice
- minimize the risk of contamination, cross-contamination, confusion, and errors in the preparation process
- ensure the quality of drugs used in clinical trials and ensure the safety of subjects.
In the past, the management of drugs for use in clinical trials in China was relatively vague. The production of commercial products needs to meet GMP standards, clinical trial research needs to meet Good Clinical Practice (GCP), and non-clinical research (laboratory) needs to meet Good Laboratory Practices (GLP). However, the management of drugs for use in clinical trial drugs was not clear enough.
The appendix is applicable to the preparation of drugs for clinical trials including experimental drugs and placebos. The GMP is also applicable to marketed drugs used as control drugs or test drugs, including changes in packaging and labeling.
The main highlights of the new GMP for China clinical trials for drugs:
Responsible person for release of the clinical trial drug
- The applicant shall nominate a responsible person for release of the clinical trial drug.
- Before approving the release, the responsible person for release shall conduct a quality evaluation of each batch of drugs for the clinical trial to ensure that they meet the laws, regulations and technical requirements.
- The quality evaluation of the drugs for the clinical trial shall have clear conclusions, such as approval for release, non-release or other decisions, and these conclusions shall be signed by the responsible person for release.
- A record review of the release of drugs for clinical trials shall be issued.
Creation of a drug file for the clinical trial
- The applicant shall establish a drug file for clinical trials, and continuously update it with the progress of drug research and development to ensure traceability.
- The file shall be used as the basis for the assessment of the release of drugs for clinical trials. When drugs for clinical trials are prepared in different steps at different sites, the applicant shall summarize and save relevant documents such as stability data, storage and transportation conditions, batch production records, etc. of all the sites.
- The files of drugs used in clinical trials shall be kept for at least 2 years after the delisting of the drugs. If the drug is not approved for marketing, it shall be kept for 2 years after the end of the clinical trial or after the termination of the registration application.
Preparation of drugs for clinical trials
- The preparation of drugs for clinical trials should be able to ensure the uniform quality of the same batch of products. When drugs for clinical trials are prepared at different sites, a study on the comparability of drug quality between different sites shall be carried out.
The full appendix can be found here.Victoria Caldy
CISEMA
Business Development & Marketing Director
victoria.caldy@cisema.comcisema.com------------------------------
Victoria Caldy
Business Development & Marketing Director
Hong Kong
victoria.caldy@cisema.com------------------------------