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In order to implement the "Opinions of the General Office of the State Council on Fully Deepening the Reform of Drug and Medical Device Supervision and Promoting the High quality Development of the Pharmaceutical Industry" (Guobanfa [2024] No. 53), improve the quality of generic drug application materials, and promote the improvement of generic drug quality, the Drug Evaluation Center has organized the drafting of the "Requirements for Writing Pharmaceutical Materials in the Second Module of Chemical Drug Generic Drug Market License Application (Raw Material) (Trial)" and the "Requirements for Writing Pharmaceutical Materials in the Second Module of Chemical Drug Generic Drug Market License Application (Preparation) (Trial)" (hereinafter referred to as the writing requirements, see attachments 1 and 2) based on the practice of drug evaluation.
The 2025 edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the "Chinese Pharmacopoeia") has been promulgated by the National Medical Products Administration and the National Health Commission in Announcement No. 29 of 2025, and will be implemented from October 1, 2025.
On December 18th, the industrialization project for the research and development of cardiovascular products and high-value consumables by Yixin Medical was officially unveiled in Hefei. As a leading global provider of cardiovascular intervention product solutions, the world's first non-invasive heart failure monitoring and management device independently developed by Heart Medical has opened a new era of non-invasive monitoring for heart failure disease management and injected new momentum into the biopharmaceutical industry in Hefei.
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