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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.
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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.
