The National Medical Products Administration (NMPA) has released a draft proposal titled “Announcement on Strengthening the Supervision and Management of Drug Entrusted Manufacturing (draft proposal)” 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.
Quality Management Alignment and Evaluation
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.
Drug Surveillance System and Access Rights
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.
Regulations for Multiple MAH Commissions
If an entrusted manufacturer accepts commissions from multiple MAHs to produce the same variety or holds the same variety itself, separate process regulations should be formulated. Material management and production processes must be independent and strictly distinguished. Shared materials, if any, should undergo strict evaluation.
Stability Assessment and Inspection Capabilities
The stability assessment work of the MAH can be conducted by themselves or entrusted to qualified third-party inspection agencies, but not to the manufacturer producing the drug. Both the MAH and the entrusted manufacturer are encouraged to possess inspection capabilities suitable for the entrusted production varieties. For critical varieties such as sterile drugs, if the MAH entrusts the manufacturer with inspection, at least one batch of finished products should be sampled for every 10 batches produced.
Unified Inspection and Change in MAH
In cases where parent and subsidiary companies or different subsidiaries under the same quality management system entrust the production of drugs, the entrusted manufacturer can conduct unified inspection. If any change occurs to the MAH, the provincial medical products administration bureau where the entrusted manufacturer is located shall conduct a strict review.
Encouragement and Restriction of Entrusted Manufacturing
Entrusted manufacturing is encouraged for innovative drugs, clinically urgent drugs determined by health authorities, drugs urgently needed to respond to public health emergencies, and drugs for treating rare diseases. Conversely, drugs with low clinical value and severe homogenization should not be commissioned for production in principle.- Flcube.com
