ISSUING AUTHORITY:

National Medical Products Administration

DATE OF ISSUANCE:

October 17, 2023

EFFECTIVE DATE:

October 17, 2023

On October 17, 2023, the Announcement of the National Medical Products Administration on Strengthening the Supervision and Management of Contract Manufacturing by Marketing Authorization Holder (“Announcement”) was promulgated by the National Medical Products Administration (NMPA),which came into effect on October 17, 2023. The Announcement reflects the latest regulatory requirements of contract manufacturing by the marketing authorization holders (“MAHs”) in China after the issuance of the Measures for the Supervision and Administration of Drug Production (2020). Highlights of the Announcement are summarized below.

Firstly, in accordance with the Announcement, a stricter approval procedure of drug production licenses shall be implemented by NMPA. When a drug MAH entrusting drug production applies for a drug production license, it is required to submit the Notice of the Drug GMP Conformity Inspection, and the Opinions of Approval of Entrusted Production issued by the medical products administrative department of the province where the contract manufacturing organization (“CMO”) is located after the on-site inspection is carried out. Where the CMO has an adverse record in its history, the entrusting MAH shall submit the On-site Inspection Report on the GMP Compliance of the CMO, the Assessment Report on the Inspection Ability of the CMO, and the Evaluation Report on the Implementation of Rectification for Violations of Laws and Regulations of the CMO.

Additionally, the Announcement emphasizes that MAHs entrusting production of drugs shall be responsible for the establishment of the quality management system(“QMS”) covering the whole manufacturing process. MAHs shall evaluate and approve the QMS of the main material suppliers through regular on-site inspections, manage the incoming inspection of raw materials, auxiliary materials, packaging materials and containers in direct contact with crude drugs, and regularly conduct spot checks and audits on the incoming inspection results of the CMOs to ensure that the relevant materials comply with the requirements for medicinal use and statutory standards. Furthermore, MAHs shall conduct quality inspections on drugs on its own, which can also be conducted by CMOs under the supervision of the MAHs. If some individual inspection items involve professional inspection equipment with high cost and less frequent use, MAHs shall entrust any third-party inspection institutions with qualifications after reporting to the medical products administrative department of the province where the MAHs are located.

The Announcement also stipulates a higher standard of supervision of contract manufacturing. All provincial medical products administrative departments are required to urge the MAHs to conduct comprehensive self-inspections in accordance with the relevant regulations and to focus on supervision and inspection of the whole process of quality management of the MAHs’ commissioned production. Moreover, if the MAHs and the CMOs are in distinct provisions, they shall be supervised under the territorial principle, the medical products administrative departments where the CMOs are located shall cooperate with that where the MAHs are located in the regular and spot inspections of the CMOs and the entrusted production varieties.

Reference:

国家药监局关于加强药品上市许可持有人委托生产监督管理工作的公告