Aoqin signed a memorandum of cooperation to better serve traditional Chinese patent medicines and simple preparations "Hengqin R&D+Macau registration"
The Drug Administration of the Macao Special Administrative Region Government (hereinafter referred to as the "Drug Administration") and the Commercial Service Bureau of the Hengqin Guangdong Macao Deep Cooperation Zone (hereinafter referred to as the "Commercial Service Bureau of the Cooperation Zone") signed the Memorandum of Cooperation on the docking mechanism for the R&D and innovation services of traditional Chinese patent medicines and simple preparations in the Hengqin Guangdong Macao Deep Cooperation Zone in Macao (hereinafter referred to as the "Memorandum") on the 7th, jointly building a service channel of "Hengqin R&D+Macao registration", and deepening the convergence of the rules of Qinhuangdao Macao drug administration.
According to the memorandum, the innovative traditional Chinese patent medicines and simple preparations developed in the cooperation zone and intended to be registered and listed in Macao can be included in the docking service channel after the initial review and recommendation of the Commercial Service Bureau of the cooperation zone and the review and confirmation of the Macao Food and Drug Administration. The Macao Food and Drug Administration will intervene in the research and development stage in advance, providing pre guidance on application paths, registration technical requirements, and data standardization to help companies reduce trial and error costs.
In addition, for clinical urgently needed innovative varieties jointly determined by the drug regulatory departments of the two places, the Macao Drug Administration will also provide full lifecycle tracking services covering pharmaceutical research, preclinical research, clinical trials, registration application, review and approval, and the initial stage after listing.
Zhang Wenji, Director of the Commercial Service Bureau of the Cooperation Zone, said that this cooperation is another landmark innovation measure for the Cooperation Zone to deepen the convergence of Qinhuangdao and Macao drug regulatory rules. It will give full play to the advantages of the cooperation zone's pharmaceutical industry cluster, provide full process precision services for innovative traditional Chinese patent medicines and simple preparations registration in Australia, and promote the coordinated development of Qinhuangdao and Macao Chinese medicine industry to a new level.
It is reported that the Qinao drug regulatory department has established a regulatory cooperation mechanism for the use of some drugs already listed in Macau in the cooperation zone. The signing of this memorandum marks that the cooperation between the two sides has expanded from "Macao medicine entering Hengqin" to "Hengqin medicine going to Macao", realizing the two-way empowerment of cross-border pharmaceutical services, and officially opening up the efficient channel for the cooperation zone to research, develop and innovate traditional Chinese patent medicines and simple preparations to register and list in Macao. (Looking into the New Era)
