China News Service, Guangzhou, July 7 (Reporter Cai Minjie) The Guangdong Provincial Drug Administration released the third batch of the Guangdong-Hong Kong-Macao Greater Bay Area clinical urgent need to import Hong Kong and Macao medicines and medical devices on its official website on the 7th.
In the catalogue announced this time, a total of 4 new drugs and 8 medical devices have been introduced.
The medical systems of Guangdong, Hong Kong and Macao are different. Breaking the institutional barriers and achieving greater breakthroughs in information exchange, mutual recognition of qualifications, and resource sharing is an important part of promoting the construction of the "Healthy Bay Area".
The "Guangdong-Hong Kong-Macao Greater Bay Area Drug and Medical Device Supervision Innovation and Development Work Plan" proposes that designated medical institutions operating in 9 mainland cities in the Greater Bay Area use drugs that are urgently needed clinically and that have been listed in Hong Kong and Macau, and that they use drugs that are urgently needed clinically and that have been purchased and used by public hospitals in Hong Kong and Macau. , Medical devices with advanced clinical application.
In August last year, the "Hong Kong-Macao Pharmaceutical Machinery" policy was officially extended and implemented in mainland cities in the Guangdong-Hong Kong-Macao Greater Bay Area.
The third batch of announcements showed that the four newly introduced new drugs were ipilimumab injection, incoxil, iridumumab and baclofen injection.
Medical institutions approved for import use include Hong Kong University Shenzhen Hospital, Guangzhou United Family Hospital and Zhongshan Chen Xinghai Hospital.
Among the 8 newly added medical devices, including Brilliant Blue G Blue Domain Stain for Ophthalmic Surgery and Trypan Blue Lens Anterior Capsule Staining Solution, 2 kinds of medical devices used in ophthalmology, the approved medical institution for import and use is Zhuhai Ximarin Shunchao eye hospital.
In addition, since lorlatinib tablets (ie lorlatinib tablets) were approved for listing in the mainland on April 27 this year, the third batch of announcements also moved lorlatinib tablets out of the first batch of Guangdong-Hong Kong-Macao Greater Bay Area A catalogue of medicines and medical devices imported from Hong Kong and Macao is urgently needed for clinical use in the Mainland.
At the same time, in order to improve the accessibility of international advanced medical devices, on June 20 this year, the "Guidelines for the Declaration of Non-first-time Use of Clinically Urgently Needed Drugs and Medical Devices Imported from Hong Kong and Macao by Designated Medical Institutions in the Guangdong-Hong Kong-Macao Greater Bay Area" was released.
This guideline aims to simplify the application materials, review and approval process, and compress the approval process for designated medical institutions to declare the drugs and medical devices that have been approved by their institutions, or to declare drugs and medical devices that have been included in the catalogue of drugs and medical devices that are urgently needed to be imported into Hong Kong and Macao in the Guangdong-Hong Kong-Macao Greater Bay Area. time.
On July 4, the Guangdong Provincial Drug Administration announced that it had received a "non-initial declaration" submitted by the Shenzhen Hospital of the University of Hong Kong, which was the previously approved benralizumab prefilled injection pen. , The magnetic controllable extension titanium rods are approved and sent on the day of acceptance.
Compared with the approval time limit for the first application, the total number of application materials for non-first application is reduced by 50%, and the approval time limit is shortened by 56% on average.
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