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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).
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NMPA Announcement on the Applicability of ICH Guideline E11A: Pediatric Extrapolation (No. 139, 2024)
2025-02-19
To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline E11A: Pediatric Extrapolation (hereinafter referred to as the E11A Guidelines).
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Ebronucimab Injection Approved for Marketing by China NMPA
2025-02-19
Recently, the Ebronucimab Injection (trade name: 伊喜宁) of Kangrong Dongfang (Guangdong) Pharmaceutical Co., Ltd. is approved for marketing by China NMPA.
