ISSUING AUTHORITIES:

National Medical Products Administration

DATE OF ISSUANCE:

June 23, 2022

EFFECTIVE DATE:

June 23, 2022

On June 23, 2022, the Department of Comprehensive Affairs, Planning, and Finance Affairs of the National Medical Products Administration issued the Implementation Plan for Supporting Marketing Authorization Holders from Hong Kong and Macao in the Manufacture of Medicinal Products in Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area and the Implementation Plan for Supporting Medical Device Registrants from Hong Kong and Macao in the Manufacture of Medical Devices in Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area (hereinafter collectively referred to as the “Implementation Plans”).

The Implementation Plans have clarified the legal procedures and requirements for cross-border commissioned production of drugs and medical devices to be conducted by Marketing Authorization Holders from Hong Kong and Macao. To be specific, the scope of application, work procedures, reporting paths and information requirements, process management and time limits, fees, and the regulatory agency's division of responsibility for the licensee from Hong Kong or Macao who obtained the import drug registration certificate or medical device registration certificate from NMPA (hereinafter collectively referred to as “licensees”) are clearly stipulated by the Implementation Plans.

Licensees may only entrust a manufacturer of medicinal products with production if it meets all the following criteria; its registered address and manufacturing site is in one of the nine mainland cities in the Guangdong-Hong Kong-Macao Greater Bay Area, it has obtained a Manufacturing Permit for Medicinal Products, the product falls within the corresponding scope of manufacture, or has passed the corresponding GMP compliance inspection.

According to the Implementation Plans, Hong Kong and Macao licensees using cross-border entrusted production procedures of imported drugs or medical devices must follow four steps: first, designate domestic corporate enterprises; second, conclude agreements on authorized manufacture; third, add the corresponding scope of manufacture of authorized manufacturers; fourth, Hong Kong and Macao drug marketing license holders must add manufacturing sites for medicinal products in China.

The Implementation Plans have opened up a new channel for cross-border commissioned production of drugs and medical devices, however, it has not yet clarified the issue of cross-border commissioning of pharmaceutical products for marketing. As the requirements and conditions for such cross-border consignment production are relatively demanding, the detailed implementation remains to be observed.

Reference:

国家药监局综合司关于发布《支持港澳药品上市许可持有人在大湾区内地9市生产药品实施方案》和《支持港澳医疗器械注册人在大湾区内地9市生产医疗器械实施方案》的通知