On April 19, the Guangdong MPA (Medical Products Administration) announced the first approved drug product and medical device arriving at the University of Hong Kong – Shenzhen Hospital (HKU-SZH). The drug is an Anti-D (Rho) immunoglobulin injection product and the medical device is a magnetically controlled growing titanium rod. Both products have already been delivered to the HKU-SZH on April 16 for clinical use.
This is a major breakthrough since the Greater Bay Area initiative (currently known as the 港澳药械通 policy in Chinese) was announced by the Chinese and Hong Kong governments to permit the use of Hong Kong-registered drugs and medical devices in designated Hong Kong-owned healthcare institutions in the Greater Bay Area – without prior NMPA registration.
In addition, 54 imported new drugs and medical devices from Hong Kong were selected by the HKU-SZH (reported by Shenzhen Daily on March 24, 2021), and are currently being reviewed by the Guangdong MPA for approval. According to Dr. Lo Chung-mau, the chief executive of the HKU-SZH, the medical devices cover orthopaedic, cardiovascular and surgical products and are selected based on the following factors:
- Products urgently needed for clinical use
- Products cannot be substituted in China
- Products featuring functionalities better than the currently existing products in China to treat patients
Dr. Lo Chung-mau also indicated that the 54 imported products could be accessible in the HKU-SZH as soon as June 2021.
The details of the 54 products or how they were selected has not yet been revealed but it is an interesting development in the Greater Bay Area regulatory pathway.
Cisema recently held a webinar with where we discussed the Greater Bay Area pathway in more detail. You are invited to watch the recording here.
By Jacky Li. Contact Cisema if you would like to learn more.
