The Macau Food and Drug Administration and the Commercial Services Bureau of the Cooperation Zone signed a memorandum to open up the Hengqin R&D + Macau registration service channel

China News Service, Macau, September 7 (Reporter Zheng Jiawei) The Food and Drug Administration of the Macau SAR Government (hereinafter referred to as the "Food and Drug Administration") and the Hengqin Guangdong-Macao Deep Cooperation Zone Commercial Service Bureau (hereinafter referred to as the "Cooperation Zone Commercial Service Bureau") signed the "Memorandum of Cooperation on the Service Docking Mechanism for the Registration and Listing of Innovative Chinese Patent Medicines in Macao in the Hengqin Guangdong-Macao Deep Cooperation Zone" (hereinafter referred to as the "Memorandum") to jointly build a "Hengqin R&D + Macao Registration" service channel and deepen the connection between Hengqin and Macao drug regulatory rules.

According to the memorandum, innovative Chinese patent medicines developed in the cooperation zone and intended to be registered and marketed in Macao can be included in the docking service channel after being initially recommended by the Commercial Services Bureau of the cooperation zone and reviewed and confirmed by the Macao Food and Drug Administration. The Macau Food and Drug Administration will intervene in advance during the research and development stage to provide advance guidance on the application path, registration technical requirements and data standardization to help companies reduce trial and error costs.

In addition, for innovative varieties that are urgently needed for clinical use jointly determined by the drug regulatory authorities of the two places, the Macao Food and Drug Administration will also provide full life cycle tracking services covering pharmaceutical research, preclinical research, clinical trials, registration application, review and approval to the early post-marketing stage.

Zhang Wenji, director of the Commercial Services Bureau of the Cooperation Zone, said that this cooperation is another landmark innovative measure for the cooperation zone to deepen the connection between Qintao and Macao’s drug regulatory rules. It will give full play to the cooperation zone’s pharmaceutical industry agglomeration advantages, provide full-process precision services for the registration of innovative Chinese patent medicines in Australia, and promote the coordinated development of Qintao and Macao’s traditional Chinese medicine industry to a new level.

It is reported that the drug regulatory department of Qin'ao has established a regulatory coordination mechanism for "some drugs already on the market in Macao to be used in the cooperation zone." The signing of this memorandum marks the expansion of the cooperation between the two parties from "Macao medicines entering Hengqin" to "Hengqin medicines going to Macao", realizing two-way empowerment of cross-border pharmaceutical services, and officially opening up an efficient channel for the cooperation zone to develop innovative Chinese patent medicines to be registered and listed in Australia. (over)