China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Provisions on the Supervision and Administration of Marketing Authorization Holder Implementing Drug Quality Subject Responsibilities,” and is soliciting public feedback until December 9. The document aims to enhance the quality management responsibilities of Marketing Authorization Holders (MAHs) in the country.
Scope of the Provisions
The provisions are applicable to MAHs’ implementation of main body responsibilities in terms of drug quality, production, and marketing activities, as well as the legal supervision and management of these activities. MAHs are required to improve their pharmaceutical quality management systems in line with production, trading, and vigilance quality management standards, ensuring the safety, effectiveness, and quality controllability of the entire drug lifecycle.
Management and Accountability
The document stipulates that MAHs must establish a management department with clear responsibilities, allocate appropriate management personnel based on the scale of drug production and operation, and define the roles of drug research and development, production, quality, sales, vigilance, and post-marketing research. This ensures compliance with relevant quality management specifications.
Operational Requirements
Additionally, the document outlines specific responsibilities and requirements for MAHs in areas such as production management, quality management, raw and auxiliary materials, packaging materials, and change management. It also details how MAHs and relevant personnel should implement mechanisms for batch audits, monthly analyses, annual reports, self-inspections, training, and more.-Fineline Info & Tech