Clinical trials GMP management specification first issued its draft in July 2018 aiming to help prepare drugs for clinical trials (including test drugs and placebo), and for changes in packaging and labeling for already marketed drugs as comparator and test drugs.
On January 18, 2022, the NMPA (National Medical Products Administration) issued the new appendix (draft) of the GMP (Good Manufacturing Practice) for drugs for clinical trials.
Key changes to previous clinical trials GMP management specification
- Implementation of clinical batch release.
- Applicant should establish a filing system by product category.
- Standardize the changes in management during the clinical period.
- Keep the intra- and inter-batch consistent for clinical trial drugs.
- Clinical trial drugs require the risk assessment of collinearity and cleaning validation.
- A complete sample retention management system for drugs used in clinical trials.
By Yu Fang and Jacky Li. Contact Cisema if you would like to learn more.