CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
ity and outsource manufacturing work to other manufacturers. In the event of outsourcing the manufacturing and/or sub-packaging, the man- ufacturing enterprise that carries out the manu- facture and/or sub-packaging also has to obtain the corresponding manufacturing licence, which is valid for five years and is renewable for anoth- er five years and six months before it expires. To further implement the responsibility of MAHs in ensuring the quality and safety of outsourced drug manufacturing, since October 2023 the NMPA has imposed more stringent and detailed requirements in terms of licensing, quality man- agement and supervision of outsourced drug manufacturing. The NMPA has developed cor- responding on-site inspection guidelines, which ensure that MAHs and manufacturing enterprises have more detailed reference criteria. In recent years, the NMPA continuously issued drafts for comments in the regulations to supervise the manufacturing of exported drugs, outlining the fundamental compliance requirements for the manufacturing of exported drugs. Medical Devices In line with the Measures for the Supervision and Administration of Medical Device Produc- tion (2022 revision), the types of authorisation for medical device manufacturers differ depending on the classification of devices. • Class I devices: the manufacturer will conduct a filing with the provincial MPA for the manu- facturing of Class I devices. • Class II and III devices: a manufacturing licence will be granted by the provincial MPA following the result of the review and on-site examination. A filing for Class I devices does not specify the duration of authorisation, while a manufacturing
licence for Class II and III devices is valid for five years and can be renewed for another five years within 30 to 90 working days prior to expiry. To ensure the quality and safety of contract manu- facturing of medical devices, the NMPA has established detailed requirements for quality management and supervision of contract man- ufacturing of medical devices since June 2024, which aims to fully implement the responsibilities of medical device registrants. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices In support of the revised DAL (2019), the SAMR officially implemented the Measures for the Supervision and Administration of Drug Quality in Operation and Usage in January 2024, and the NMPA issued the Announcement on Further Improving the Supervision and Administration of Pharmaceutical Distribution in April 2024. These measures further clarify the conditions, proce- dures and quality management requirements for obtaining a drug distribution licence. Generally, a wholesale drug distributor must maintain a drug distribution licence, with an exception for drug MAHs that sell their drugs as a wholesaler without obtaining a drug distribu- tion licence. The licence is valid for five years and can be renewed two to six months before expiry. The relevant provincial MPA will review the application, conduct on-site examinations and decide whether to approve it. An application for changes to licensed matters of a drug distribution licence must be submit- ted to the issuing authority, which will make its decision within 15 days from the date of receiv-
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