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Measures facilitate approval of 48 first-in-class innovative drugs
China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released on Tuesday by the National Medical Products Administration.
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China approves 48 innovative drugs in 2024
China approved 48 first-in-class innovative drugs in 2024, covering nearly 20 therapeutic areas, including oncology, neurological disorders, endocrine diseases and anti-infective medicines, according to a report released by the National Medical Products Administration on Tuesday.
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Ebronucimab Injection Approved for Marketing by China NMPA
Recently, the Ebronucimab Injection (trade name: 伊喜宁) of Kangrong Dongfang (Guangdong) Pharmaceutical Co., Ltd. is approved for marketing by China NMPA.
- NMPA Announcement on the Applicability of ICH Guideline E11A: Pediatric Extrapolation (No. 139, 2024)
- NMPA Announcement on the Applicability of ICH Guideline M12: Drug Interaction Studies and Its Q&A Document (No. 130, 2024)
- NMPA Announcement on Issuing the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders
