The approval time limit is shortened by 56% on average! This new regulation was successfully implemented in Guangdong
2022-07-05
A few days ago, Guangdong Provincial Drug Administration received the "non first application" submitted by Shenzhen Hospital of the University of Hong Kong, which were previously approved benalizumab pre filled injection pen and magnetic controllable extension titanium rod, which were approved and sent on the day of acceptance. This is a vivid practice after the provincial drug administration and the Provincial Health Commission issued the guidelines for the declaration of drugs and medical devices urgently needed to be imported from Hong Kong and Macao for non first-time use by designated medical institutions in the mainland of Guangdong Hong Kong Macao Great Bay area on June 20. The compass applies for the approved drugs and medical devices of the designated medical institutions, or the drugs and medical devices that have been included in the catalogue of drugs and medical devices urgently imported from Hong Kong and Macao in the mainland of Guangdong, Hong Kong and Macao Great Bay area, simplifies the application materials and the review and approval process, reduces the approval time, improves the accessibility of international advanced drugs and devices, and effectively maintains the safety of people's drug use. When the designated medical institution applies for the approved drugs and medical devices, the number of application materials is reduced from 9 to 4, and the time limit for approval is promised to be 1 working day; For the drugs and medical devices that have been included in the catalogue, the number of application materials is reduced to 5. Compared with the approval time limit of the first declaration, the application materials of non first declaration are reduced by 50% in general, and the approval time limit is shortened by 56% on average. (Xinhua News Agency)
Edit:Li Jialang Responsible editor:Mu Mu
Source:southcn.com
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