Supporting Marketing Authorization Holders from Hong Kong and Macao in the Manufacture of Medicinal Products in the Guangdong-Hong Kong-Macao Greater Bay Area
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:
國家藥監局綜合司關于發布《支持港澳藥品上市許可持有人在大灣區內地9市生產藥品實施方案》和《支持港澳醫療器械注冊人在大灣區內地9市生產醫療器械實施方案》的通知
