CMC considerations of manufacturing site changes for marketed therapeutic recombinant protein drugs from regulatory review
10.13200/j.cnki.cjb.004414
- VernacularTitle:已上市治疗用重组蛋白药物生产场地变更药学研究审评思考
- Author:
SAI Wenbo
- Publication Type:Journal Article
- Keywords:
Life-cycle regulatory management;
Marketed therapeutic recombinant protein drugs;
Manufacturing site change;
Risk assessment;
Technical requirements;
Comparability study
- From:
Chinese Journal of Biologicals
2025;28(02):252-256
- CountryChina
- Language:Chinese
-
Abstract:
With the continuous improvement of China's drug regulatory laws and regulations, Life-cycle regulatory management has become a key means and an inevitable development trend to ensure the safety of public drug use. The management of post-approval changes to biological products is gradually shifting towards the risk-based model from the item-based model.In recent years, there has been a significant increase in supplementary applications for manufacturing site changes of marketed therapeutic recombinant protein drugs. However, the risks associated with manufacturing site changes vary under different circumstances. Therefore, the research that needs to be carried out is also different. This paper provides an in-depth discussion on three key aspects: risk assessment and grading, general requirements and special considerations for pharmaceutical research, and common application issues. It outlines general requirements for manufacturing site change, aiming to offer valuable insights for industry needs. Through the collaborative efforts between regulatory authorities and the industry, patient rights and interests can be effectively protected, and high-quality drugs can be made available to the public.
