The Drug Administration of Guangdong Province recently announced that the first cross-border drug production in the Guangdong–Hong Kong–Macao Greater Bay Area has been officially put into production and listed, which marks the successful implementation and effectiveness of the policy of the state to support drug marketing license holders from Hong Kong and Macao to produce drugs in 9 cities in the Mainland of the Greater Bay Area. According to the introduction of Guangdong Drug Administration, the first cross-border drug production in the Guangdong–Hong Kong–Macao Greater Bay Area is the vitamin C Effervescent tablet of the Hong Kong United Laboratories Co., Ltd., which is entrusted by the company to produce by its affiliated company in Zhongshan, Guangdong, and has recently been put into production, listed and sold in the mainland. In the past, Hong Kong and Macao drugs were managed based on overseas drugs, and most of the drug production sites were in Hong Kong and Macao. However, due to the limited production sites of manufacturing factories in Hong Kong and Macao, production capacity is prone to be insufficient. According to previous laws and regulations, there is no precedent for overseas drug marketing license holders to produce drugs cross-border in mainland China. In order to promote the deep integration and coordinated development of the pharmaceutical industry in the Guangdong–Hong Kong–Macao Greater Bay Area, the State Food and Drug Administration and other departments jointly issued the Work Plan for the Innovative Development of Drug and Medical Devices Supervision in the Guangdong–Hong Kong–Macao Greater Bay Area in November 2020, proposing to carry out the reform of the drug marketing license holder system in the Guangdong–Hong Kong–Macao Greater Bay Area, and support the drug marketing license holders in Guangdong–Hong Kong–Macao Greater Bay Area to produce their drugs in eligible enterprises in 9 cities in the mainland of the Guangdong, Hong Kong and Macao Greater Bay Area. In June 2022, the State Food and Drug Administration issued the Implementation Plan for Supporting Drug Marketing License Holders from Hong Kong and Macao to Produce Drugs in 9 Mainland Cities of the Greater Bay Area, further clarifying the specific work content related to supporting cross-border production of drugs from Hong Kong and Macao, and making detailed provisions on the scope of policy application, work procedures, application paths and data requirements, so as to provide clear guidance for the reform of the drug marketing license holder system in the Guangdong–Hong Kong–Macao Greater Bay Area. The relevant policies allow Hong Kong and Macao drugs to implement a "overseas holding+domestic production" model, which is beneficial for the Hong Kong and Macao regions to take advantage of the advantages of mainland drug production and manufacturing in the Greater Bay Area and gradually solve the problems of insufficient production land and high production costs. The Drug Administration of Guangdong–Hong Kong–Macao Greater Bay Area said that in the future, the reform of the system of drug marketing license holders will gradually expand the policy benefits, effectively promote the transformation and upgrading of the pharmaceutical industry in Hong Kong and Macao, accelerate the integrated development of the pharmaceutical industry in Guangdong–Hong Kong–Macao Greater Bay Area, and form a complementary and interactive industrial chain. (New News Agency)
Edit：XiaoWanNing Responsible editor：YingLing
Source：Xinhua News Agency
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