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Accelerate! Accelerate! "Hong Kong Macao pharmaceutical machinery link" launched the "preliminary examination library"

2022-09-02   

On September 1, the Guangdong Provincial Drug Administration officially issued the notice on establishing the database of pre-trial varieties of drugs and medical devices urgently needed to be imported from Hong Kong and Macao in Guangdong, Hong Kong and Macao. On the same day, the database of pre-trial varieties of drugs and medical devices urgently needed to be imported from Hong Kong and Macao (hereinafter referred to as the pre-trial database) in Guangdong, Hong Kong and Macao Bay area and the mainland was officially launched. The purpose of the preliminary examination database established by the provincial drug administration is to do a good job in the declaration service of designated medical institutions for clinically urgently needed imported drugs and medical devices from Hong Kong and Macao (hereinafter referred to as urgently needed drugs and devices), steadily promote the construction of the policy system of "Hong Kong Macao drugs and devices link", improve the availability of research materials related to urgently needed drugs and devices, shorten the preparation time of application materials, and enhance the policy participation enthusiasm of overseas listing permit holders. Taking drugs as an example, information such as adverse drug reaction overview, clinical use overview, ethnic difference use risk assessment, and regular benefit risk assessment usually involve trade secrets, which can be used by designated medical institutions after internal hierarchical approval and authorization of overseas listing holders. Usually, the authorization process takes 3 months or more. The pre-trial database will change the passive waiting of data acquisition into active service, shorten the preparation time of the declaration data of designated medical institutions, and reduce the number of applications for import use. In combination with the measures of speeding up the first application and simplifying the non first application, the "Hong Kong Macao pharmaceutical machinery link" policy has realized the time limit compression of the whole process from data acquisition, application material preparation to review and approval. On the same day, Weicai (Suzhou) Trading Co., Ltd. conveyed the relevant data of Weimian (leiboleisheng tablets) on the prequalification database system, and it has been successfully included in the prequalification database. (Li Xinshe)

Edit:Li Jialang Responsible editor:Mu Mu

Source:southcn.com

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