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Implantable Cardiac Pacing Lead Approved for Marketing
2025-02-19
Recently, the innovative product "Implantable Cardiac Pacing Lead" of MicroPort Sorin CRM (Shanghai) Co., Ltd. is approved for marketing by China NMPA.
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Garsorasib Tablets Approved with Conditions for Marketing by China NMPA
2025-02-19
Recently, the Class 1 innovative drug Garsorasib Tablets (trade name: 安方宁) of Shanghai Chia-tai Tianqing Pharmaceutical Technology Development Co. Ltd. is approved with conditions for marketing through the priority review and approval procedure by NMPA in China.
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Zorifertinib Hydrochloride Tablets Approved for Marketing by China NMPA
2025-02-19
Recently, the Class 1 innovative drug Zorifertinib Hydrochloride Tablets (trade name: 泽瑞尼) of Alpha Biopharma (Jiangsu) Co., Ltd. is approved for marketing by China NMPA.
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NMPA Announcement on the Applicability of ICH Guideline M12: Drug Interaction Studies and Its Q&A Document (No. 130, 2024)
2025-02-19
To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline M12: Drug Interaction Studies and its Q&A document (hereinafter referred to as the M12 Guidelines and its Q&A document).
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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.
