Hainan advances pharmaceutical regulatory reform, multiple pilot programs make progress

On June 30, the Hainan Provincial Medical Products Administration reported that since the release of the relevant implementation plan in April last year, reform of local regulation of pharmaceuticals, medical devices, and cosmetics has continued to advance, with progress made in areas including review and approval, application of realworld data, management of specially permitted drugs and devices, and implementation of policies for the free trade port. According to the report, Hainan has obtained pilot qualification for reform of the review and approval procedures for supplemental applications for domestically marketed drugs and supplemental applications for chemically synthesized drugs produced overseas. Through mechanisms such as "service upfront," "acceptance with missing documents allowed," and "completion within a time limit," it has provided preapplication guidance for some products, shortening review times. At the same time, Hainan has also promoted the "Lecheng research and use + Hainan production" model, improved the mechanism for applying realworld data, and supported the accelerated registration and local transformation of more imported drugs and devices. In terms of management of specially permitted drugs and devices, Hainan has established a prereview service and a filing prereview database to improve approval efficiency, and has expanded the coverage of "first used in China" products. Focusing on the core policies of the free trade port, the local government has also advanced qualification applications for "zerotariff" imported drugs and devices, a pilot program for electronic labels on dutyfree cosmetics from outlying islands, and optimized regulatory services for imported cosmetics at the China International Consumer Products Expo, serving the development of the pharmaceutical industry and institutional openingup.