The National Medical Products Administration (NMPA) has released a draft proposal titled \u201cAnnouncement on Strengthening the Supervision and Management of Drug Entrusted Manufacturing (draft proposal)\u201d and is soliciting public feedback until December 10, 2024. This initiative aims to enhance the oversight and management of drug manufacturing processes where production is entrusted from one party to another.<\/p>\n\n\n\n
Quality Management Alignment and Evaluation<\/strong> Drug Surveillance System and Access Rights<\/strong>
The draft proposes that entrusted manufacturers must have institutions, personnel, and quality management systems that are aligned with the entrusted products, ensuring effective connectivity between the quality management systems of both the commissioning and manufacturing parties. It is imperative for entrusted manufacturers to establish an evaluation mechanism for the quality management system of the commissioning party. Any quality risk in drug manufacturing should lead to the termination of cooperation.<\/p>\n\n\n\n
During the entrusted production period, entrusted manufacturers are required to establish a drug surveillance system and cannot refuse on-site personnel from the Marketing Authorization Holder (MAH) access to clean areas for any reason.<\/p>\n\n\n\n