Shenzhen Government Online
Intl. new drug, medical device imported
From: Shenzhen Daily
Updated: 2021-04-19 09:04

The first batch of international advanced medicine and medical equipment imported under the “Hong Kong and Macao Medicine and Equipment Connect” policy arrived at the University of Hong Kong-Shenzhen Hospital (HKU-SZH) on Friday, and will soon be put into clinical use at the hospital.


The new medicine, anti-D (rh) immunoglobulin, is a medication used to prevent hemolytic disease of the fetus and newborns in Rh-negative mothers and to treat idiopathic thrombocytopenic purpura in people who are Rh positive.


At present, the drug has not been available for use on the Chinese mainland, and Rh-negative mothers have been unable to obtain it legally.


The newly introduced medical equipment is a magnetically controlled growing titanium rod, which is used in the surgical treatment of children suffering from severe early-onset scoliosis. Compared with traditional methods, it can greatly reduce patients’ pain.


According to HKU-SZH, the new medicine and device, though currently inaccessible on the mainland, have both gained approval in foreign countries with numerous phase-III clinical research data.


The hospital has selected the medicine and device based on a number of factors such as urgency, advantage and safety.


“We need to make sure that the whole process is up to standard and that patients are allowed to use the medicine and medical device in an open and legal way,” said Lo Chung-mau, chief executive of HKU-SZH.


The hospital has been authorized to pilot the use of imported international new medicines and medical equipment under the “Hong Kong and Macao Medicine and Equipment Connect” policy, according to the work plan for the innovative development of medicine and medical device supervision in the Guangdong-Hong Kong-Macao Greater Bay Area.


The work plan, jointly issued by eight ministries and commissions last November, proposed that other medical institutions that meet the requirements can follow suit after some initial progress has been made. The pilot period will run until July 31, 2021.


At present, the provincial medical products administration is asking HKU-SZH to furnish a list of urgently needed medicines and medical devices for application and procurement.


So far, the application for import and use of new drugs for the treatment of lung cancer, lymphatic cancer and severe chronic obstructive pulmonary disease has been reviewed and approved.



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