New rules facilitate access to world's innovative drugs

Patients in the Boao Lecheng International Medical Tourism Pilot Zone in South China's Hainan province will be able to take a small amount of clinically and urgently needed imported oral drugs for their own use out of the pilot zone, according to new measures approved by the central and Hainan provincial medical and health authorities.

This is good news for many Chinese who are eagerly hoping for the latest drugs or medical devices to treat their serious chronic illnesses, said officials at a news conference held on Saturday at the Boao pilot zone, established in 2013 to create a world-class medical tourism destination and opening up the country's medical sector.

The move was an update of a preferential policy introduced in December 2018, with the State Council granting the government of Hainan province the right to approve the use of clinically urgent overseas drugs that have not yet been approved for registration and import in China, in Lecheng pilot zone, said Jia Ning, director of the Hainan Provincial Medical Products Administration.

He said under the current national regulations, it takes at least three to five years for foreign advanced innovative drugs and medical devices to enter the domestic market.

The new rules stipulate that patients should take their first doses of imported drugs at hospitals in the pilot zone and medical institutions there must formulate drug use plans and emergency plans for each patient to ensure safe use of the drugs back at home. A monitoring platform will be built soon to trace and check each patient abide by the plans and commitments in a serious manner.

As of March 27 this year, 63 batches of 64 varieties of clinically urgent medicine and medical devices have been approved for import to Lecheng pilot zone, and have been used by 285 patients, as per data from the zone administration.

Also on Saturday, it was announced that National Medical Products Administration has approved the registration of a glaucoma treatment product by US Allergan. The approval was based on the real-world clinical observation data collected in Lecheng pilot zone after evaluating ethnic differences. It is the first foreign medical device product using real-world evidence gathered in China for official registration, according to Gu Gang, director of the zone administration.

"The approval will attract more international manufacturers of advanced medical devices, pharmaceutical companies and medical institutions to settle in the pilot zone. It was also conducive to helping build the pilot zone into a gateway for foreign advanced drugs and medical devices to enter China," said Gu.