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NMPA Held 2023 ICH in China: Progress and Outlook Symposium
2023-09-13
On September 12, NMPA held 2023 ICH in China: Progress and Outlook Symposium in Beijing, to make dialogue on development and cooperation with representatives from domestic and foreign industry associations.
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Narlumosbart Injection Approved with Conditions for Marketing by China NMPA
2023-09-06
Recently, the Narlumosbart Injection (Chinese trade name: 津立生) of Shanghai JMT Biological Technology Co. Ltd. is approved with conditions through the priority review and approval procedure by China NMPA.
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NMPA Announcement on Adopting ICH Guidelines S12
2023-09-05
To align the technical standards for drug registration with international standards, the NMPA has decided upon deliberation to adopt the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines S12: Nonclinical Biodistribution Considerations for Gene Therapy Products(hereinafter referred to as S12).
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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.
