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China releases second catalog of rare diseases
2023-09-21
Chinese health authorities have recently compiled the country's second catalog of rare diseases, the National Health Commission announced Wednesday.
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NMPA Announcement on Adopting ICH Guidelines M10 Q&As and FAQs
2023-07-04
To align the technical standards for drug registration with international standards, the NMPA upon deliberation decided to adopt the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M10: Bioanalytical Method Validation And Study Sample Analysis (hereinafter referred to as M10) Q&As documents and FAQs documents.
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Equecabtagene Autoleucel Injection Approved with Conditions by China NMPA
2023-06-30
Recently, the Equecabtagene Autoleucel injection(Chinese trade name: 福可苏) of Nanjing IASO Biotechnology is approved with conditions through the priority review and approval procedure by China NMPA.
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Telpegfilgrastim Injection Approved for Marketing by China NMPA
2023-06-30
Recently, the Telpegfilgrastim injection (Chinese trade name: 珮金) of Xiamen Amoytop Biotech Co., Ltd. is approved for marketing by China NMPA.
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Pegmolesatide Injection Approved for Marketing by China NMPA
2023-06-30
Recently, the Category 1 innovative drug Pegmolesatide Injection (Chinese trade name: 圣罗莱) of Jiangsu Hansoh Pharmaceutical Group Company Limited is approved by China NMPA.
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Iruplinalkib Tablets Approved for Marketing by China NMPA
2023-06-28
Recently, the Category 1 innovative drug Iruplinalkib Tablets (Chinese trade name: 启欣可) of Qilu Pharmaceuticals Co., Ltd is approved by China NMPA.
