The National Medical Products Administration (NMPA) in China has announced an extension to the public feedback period for its draft proposal titled “Drug Standardization Management Measures.” Initially open for feedback from December 14, 2022, to January 13, 2023, the window has been extended to June 5, 2023. This initiative reflects NMPA’s commitment to introducing more rigorous drug standards to ensure the safety, efficacy, and quality of drugs within China’s healthcare system.
Draft Measures Reflect Recent Reforms and Strengthen Regulatory Framework
The “Measures” outlined by NMPA are set to reflect the reforms in the drug review and approval system over recent years. These include revisions to legal regulations such as the “Drug Administration Law” and “Vaccine Administration Law,” which are viewed as highly significant in comprehensively strengthening drug regulatory capacity. A symposium was organized from January to April 2023, gathering opinions and suggestions from relevant pharmaceutical enterprises, research and development institutions, associations, experts, and provincial bureaus.
Key Focus Areas of the Draft Measures Include:
- Establishment of three types of standard formulation procedures and requirements: “National Drug Standards,” “Drug Registration Standards,” and “Provincial Traditional Chinese Medicine Standards.” The document provides clear definitions and applications for traditional Chinese medicine, chemical raw materials, medical institution preparations, excipients, and packaging materials, setting the foundation for regulatory policies.
- Clarification of responsibilities to strengthen the main responsibilities of marketing authorization holders (MAHs).
- Encouragement of active participation from enterprises and social parties in drug standards research and improvement.
- Provision of a “green channel” to expedite the formulation or revision of national drug standards in response to drug safety or public health emergencies.
- Post-implementation of new national drug standards, MAH holders are required to conduct applicability evaluations and submit supplementary applications or changes in line with post-market change management regulations.
- A proposed transition period of 6 months is suggested for the implementation of the “Measures” to allow necessary adjustment time for enterprises.-Fineline Info & Tech
