Hainan: Promoting the improvement of the quality of generic drugs and supporting the accelerated registration and listing of first generic varieties.

The "Implementation Plan for Comprehensive Deepening of Drug, Medical Devices and Cosmetics Regulatory Reform to Promote High-quality Development of the Pharmaceutical Industry in Hainan Province" was released to the public on the 29th. It proposes to promote the improvement of the quality of generic drugs. Firstly, it supports the accelerated registration and listing of first generic varieties. Support will be provided to the first generic varieties with dedicated personnel responsible, proactive coordination, strengthened guidance, and comprehensive services, and support will be provided in the areas of review and approval, registration verification, and product inspection. Secondly, it will strengthen the regulation of contract manufacturing. Support will be given to the mutual recognition of inspection results through cross-provincial collaborative supervision, and companies with strong quality assurance and risk control capabilities will be supported to accept contract manufacturing. Guidelines for contract manufacturing management will be formulated to standardize contract manufacturing behavior. Thirdly, it supports conducting consistency evaluation of generic drug quality and efficacy. Certain financial support will be provided for varieties that meet the conditions.