Hainan: Promote improvement of quality of generic drugs and support faster registration and market entry of the first generic varieties.
The General Office of the People's Government of Hainan Province has issued a notice on the implementation of the "Hainan Province Comprehensive Deepening of Drug, Medical Device and Cosmetics Supervision Reform to Promote High-Quality Development of the Pharmaceutical Industry". It proposes to promote the quality improvement of generic drugs. Firstly, to support the accelerated registration and listing of first generic varieties. Special personnel will be responsible for first generic varieties, actively coordinating, strengthening guidance, and providing full services, supporting them in review, approval, registration verification, product inspection, etc. Secondly, to strengthen the supervision of contract manufacturing. Support cross-province collaborative supervision and mutual recognition of inspection results, support companies with strong quality assurance and risk control capabilities to accept contract manufacturing. Develop guidelines for contract manufacturing management to standardize contract manufacturing behavior. Thirdly, to support the evaluation of consistency between the quality and efficacy of generic drugs. For eligible varieties, certain financial support will be provided.
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