On November 26, 2021, the CDE (Center for Drug Evaluation) under the NMPA (National Medical Products Administration) published (No.48-2021) the technical requirements including common pharmacology issues for Pre-NDA meetings prior to innovative drugs going to market.
The Pre-NDA meeting is important to the approval of the NDA (New Drug Application) whilst focusing on key areas beneficial to the launch of new drug products, and providing applicants with ideas to improve the quality and efficiency of communication between applicants and the regulator.
The technical requirements addressed the following common issues:
- API synthesis starting material selection
- API pharmacological change research
- API-related substances research and control
- Research on mutagenic impurities
- API quality control projects
- Formulation change studies
- Formulation degradation impurity research
- Formulation quality control program and formulation dissolution
- Release studies and other aspects of common pharmacy issues and general requirements
The technical requirement also stressed that major pharmacological changes should be completed as soon as possible before the start of clinical trials. If major pharmacological changes occur after the end of the clinical trial, the drug registration process may be affected.
In order to encourage the R&D and submission to accelerate the marketing process of innovative drugs, the NMPA supports applicants to resolve pharmacology-related issues during clinical trials through communication channels such as pre-application meeting for new drug clinical trials (Pre-IND meeting), end of phase II clinical trial for new drugs (EOP II)/pre-initiation meeting for phase III clinical trials (Pre-III meeting) at different research stages.
By Sun Jinlin and Jacky Li. Contact Cisema if you would like to learn more.