
Main Responsibilities of the National Medical Products Administration (1) To supervise the safety of drugs (including traditional Chinese medicines (TCMs) and ethno-medicines, the same below), medical devices and cosmetics; to draw up regulatory policy plans, organize the drafting of laws and regulations, formulate normative documents, and supervise the implementation thereof; to research and formulate regulatory and supportive policies that encourage new technologies and new products for drugs, medical devices and cosmetics. (2) To undertake standards management for drugs, medical devices and cosmetics; to organize the formulation and publication of the Chinese Pharmacopoeia and other drug and medical device standards, organize the drafting of cosmetic standards, organize the formulation of the classification management system, and supervise the implementation thereof; to participate in formulating the National Essential Medicine List, and assist in the implementation of the national essential medicine system. (3) To regulate the registration of drugs, medical devices and cosmetics; to develop the registration system, conduct strict review and approval for marketing, improve measures to facilitate the review and approval process, and organize the implementation thereof. (4) To undertake quality management for drugs, medical devices and cosmetics; to develop Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), and supervise the implementation thereof; to develop Good Manufacturing Practices (GMP) and supervise the implementation thereof in line with NMPA's responsibilities; to develop good practices on the distribution and use of medical products and guide the implementation thereof.
解锁市场时间线与信号动态
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该公司进入各个市场的顺序 — 从最早到最新
安腾基因获CDE批准进行ATG-022三期试验
科伦博泰获SKB118临床试验批准
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NMPA-National Medical Products Administration 的国际扩张与竞争对手的对比情况
条形图显示所对比公司之间的相对规模。
列5| 公司 | 市场 | 新市场 | 势头 | 活动 | 扩张评分 |
|---|---|---|---|---|---|
NMPA-National Medical Products Administration你 | 4 | 2 | +300% | 5 | 19 |
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Chance Pharmaceuticals宣布中国NMPA接受其CXG87新药申请,这是一种创新的布地奈德/福莫特罗吸入粉剂,用于哮喘治疗,标志着公司首次新药申请及商业化里程碑。
大冢制药宣布斯贝利单抗(伊再可)获中国NMPA批准用于IgA肾病,这是全球首个获批的生物制剂,基于VISIONARY三期研究显示9个月蛋白尿降低51.2%,为疾病进展风险患者提供新选择。
恒瑞医药在2026年ASCO年会上公布CARES-336三期研究结果,显示卡瑞利珠单抗联合阿帕替尼及TACE治疗不可切除肝细胞癌患者的无进展生存期显著改善。
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