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Efsubaglutide Alfa Injection Approved for Marketing by China NMPA
2025-06-11
Recently, the Efsubaglutide Alfa Injection (trade name: 怡诺轻) of Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. is approved for marketing by China NMPA.
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NMPA Announcement on Issuing the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex of the Good Manufacturing Practice for Drugs (2010 Revision) (No.1, 2025)
2025-06-11
To implement relevant regulations such as the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, the Provisions for Drug Registration, and the Provisions for Drug Manufacturing Supervision and Administration, and to supervise and guide the standardized production of pharmaceutical excipients and pharmaceutical packaging materials manufacturers, the National Medical Products Administration has organized the formulation of the Pharmaceutical Excipients Annex and Pharmaceutical Packaging Materials Annex.
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Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry
2025-03-25
In order to thoroughly implement the important instructions and directives of General Secretary Xi Jinping on the regulation of drugs and medical devices and the development of the pharmaceutical industry, and to comprehensively deepen reforms in drug and medical device regulation to promote the high-quality development of the pharmaceutical industry, the following opinions are proposed with the approval of the State Council.
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Garsorasib Tablets Approved with Conditions for Marketing by China NMPA
2025-02-19
Recently, the Class 1 innovative drug Garsorasib Tablets (trade name: 安方宁) of Shanghai Chia-tai Tianqing Pharmaceutical Technology Development Co. Ltd. is approved with conditions for marketing through the priority review and approval procedure by NMPA in China.
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Zorifertinib Hydrochloride Tablets Approved for Marketing by China NMPA
2025-02-19
Recently, the Class 1 innovative drug Zorifertinib Hydrochloride Tablets (trade name: 泽瑞尼) of Alpha Biopharma (Jiangsu) Co., Ltd. is approved for marketing by China NMPA.
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NMPA Announcement on the Applicability of ICH Guideline M12: Drug Interaction Studies and Its Q&A Document (No. 130, 2024)
2025-02-19
To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline M12: Drug Interaction Studies and its Q&A document (hereinafter referred to as the M12 Guidelines and its Q&A document).
