Hong Kong and Macao drugs and medical devices are open in the Greater Bay Area: Handbuilding can commission production in 9 cities in the Mainland

Yangcheng Evening News reporter Chen Zeyun reported: On the evening of June 29, the Comprehensive Department of the State Drug Administration released the "Implementation Plan for Supporting Hong Kong and Macao Pharmaceutical Lishes in the Mainland of the Greater Bay Area" and "Supporting Hong Kong and Macao Medical Device Registers in the Mainland of the Greater Bay Area" "Implementation Plan for Production and Medical Device in Mainland in the Greater Bay Area" (hereinafter referred to as the plan). According to the plan, Hong Kong and Macao drugs and medical devices will open pilots in 9 cities in the Greater Bay Area to promote the reform of the Guangdong -Hong Kong -Macao Greater Bay Area Pharmaceutical Licenses and Medical Device Registration.

The plan pointed out that the reform of the holder of drug listing permits in the Guangdong -Hong Kong -Macao Greater Bay Area is allowed to allow Hong Kong and Macao drug listing licenses to commission production cross -border in the Greater Bay Area in the Greater Bay Area. Both policies are committed to further promoting the in -depth integration of the biomedical industry in the Guangdong -Hong Kong -Macao Greater Bay Area, and the common development of the pharmaceutical industry in the Guangdong -Hong Kong -Macao Greater Bay Area.

The application scope of the above two policies is held and produced in the Hong Kong Special Administrative Region or the legally registered enterprises in the Hong Kong Special Administrative Region or the Macau Special Administrative Region, and have obtained Chinese medicine and chemicals registered and listed in the country. In order to register address and production venue, both cities in the Guangdong -Hong Kong -Macao Greater Bay Area have obtained the "Drug Production License", a drug manufacturer with corresponding production scope or passing the corresponding GMP compliance inspection.

The scope of production and application of medical devices is basically the same as above. If the registrant of the medical device is a Hong Kong and Macao enterprises, the legal person established in the Greater Bay Area as an agent shall be registered for medical device changes to assist Hong Kong and Macao medical device registrars to perform their obligations to fulfill their obligations to fulfill their obligations At the same time, you should bear joint responsibility. In addition, the production address of the commissioned production agreement, the change of medical device registration certificate, and the trustee production enterprise must fulfill the reporting obligations.

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