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NMPA Announcement on Adopting ICH Guidelines Q12
2023-08-25
To align the technical standards for drug registration with international standards, the NMPA has decided to adopt the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
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Sunvozertinib Tablets Approved for Marketing by China NMPA
2023-08-23
Recently, the Category 1 innovative drug Sunvozertinib Tablets (Chinese trade name: 舒沃哲) of Dizal (Jiangsu) Pharmaceutical Co., Ltd is approved by China NMPA.
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Tafolecimab Injection Approved for Marketing by China NMPA
2023-08-16
Recently, the Tafolecimab Injection (trade name: SINTBILO®) of Innovent Biologics (Suzhou) Co., Ltd. is approved by China NMPA.
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TCM Compound Preparation Pipa Qingfei Granules Approved for Marketing by China NMPA
2023-07-27
Recently, another traditional Chinese medicine (TCM) compound preparation Pipa Qingfei granules regulated as one of the ancient classic formulae (which is a category 3.1 innovative TCM) is approved for marketing through technical evaluation.
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Cryoablation Equipment and Balloon Cryoablation Catheter Approved for Marketing
2023-08-24
Recently, the innovative products Cryoablation Equipment and Balloon Cryoablation Catheter of Cryofocus Medtech (Shanghai) Co., Ltd. are approved by China NMPA.
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Magnetic Resonance Imaging System Approved for Marketing
2023-08-16
Recently, the innovative product Magnetic Resonance Imaging System of Wuhan Verlmagin Medical Technology Co., Ltd is approved by China NMPA.
