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Iparomlimab and Tuvonralimab Injection Approved with Conditions for Marketing by China NMPA
2025-02-19
Recently, the Iparomlimab and Tuvonralimab Injection (trade name: 齐倍安) of Qilu Pharmaceuticals Co., Ltd. is approved for marketing with conditions by China NMPA. It is indicated for the treatment of recurrent or refractory cervix carcinoma patients who progressed on or after platinum-based chemotherapy.
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Ongericimab Injection Approved for Marketing by China NMPA
2025-02-19
Recently, the Ongericimab Injection (trade name: 君适达/Junshida) of Shanghai Junshi Biosciences Co., Ltd. is approved for marketing by China NMPA.
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Pradefovir Mesylate Tablets Approved for Marketing by China NMPA
2025-02-19
Recently, the Class 1 innovative drug Pradefovir Mesylate Tablets (trade name: 新舒沐) of Xi'an Gelan Xintong Pharmaceutical Co., Ltd. is approved for marketing by China NMPA. This drug is indicated for the treatment of adult patients with chronic hepatitis B, providing a new treatment option for patients.
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NMPA Announcement on Issuing the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders
2025-02-19
To implement the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, and to strengthen the management of overseas marketing authorization holders (MAHs), the National Medical Products Administration (NMPA) has formulated the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders. These provisions are hereby issued and will come into effect from July 1, 2025.
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NMPA Announcement on Including the Testing Methods for Azelaic Acid and Its Salts in Cosmetics and Other 5 Testing Methods into the Technical Specification for the Safety of Cosmetics (Edition 2015) (No. 45, 2024)
2025-02-19
The National Medical Products Administration (NMPA) has organized to formulate Testing Methods for Azelaic Acid and Its Salts in Cosmetics and other 5 testing methods, which have been reviewed and approved by the Chairman's Meeting of the NMPA's Cosmetic Standardization Technical Committee.
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NMPA Notice on Printing and Issuing the Guidelines for On-Site Inspection of the Good Supply Practice for Medical Devices
2025-02-19
The revised Good Supply Practice for Medical Devices (hereinafter referred to as the Regulations) will be implemented as of July 1, 2024. To standardize and instruct the on-site inspection of the Good Supply Practice for Medical Devices, the National Medical Products Administration (NMPA) has formulated the Guidelines for On-site Inspection of Good Supply Practice for Medical Devices (hereafter referred to as the Guidelines), which is hereby printed and issued.
