药品管理法实施条例修订
Search documents
鼓励研究和创制新药 支持临床使用
Xin Lang Cai Jing· 2026-01-27 17:52
二是加强药品生产管理。严格药品委托生产管理,压实委托生产时药品上市许可持有人的责任,明确可 以委托分段生产药品的情形。明确中药饮片、中药配方颗粒生产、销售的管理要求。 三是规范药品经营和使用。完善药品网络销售管理制度,压实药品网络交易第三方平台提供者责任。加 强医疗机构药事管理,保障使用环节药品质量。明确医疗机构配制制剂审批流程,规定医疗机构制剂调 剂使用条件和程序,支持配制儿童用医疗机构制剂,满足儿童患者用药需求。 新修订的药品管理法实施条例5月15日起施行 1月27日,新修订的《中华人民共和国药品管理法实施条例》(以下简称《条例》)公布,自5月15日起 施行。 据国家药监局相关负责人介绍,《条例》是《药品管理法》的重要配套行政法规,这次修订是《条例》 施行23年来的首次全面修订,修改的条款达到90%以上,除了第一条以《药品管理法》作为立法依据的 条款没有修改外,其余条款均有调整或者修改。 《条例》共9章89条,修订后的主要内容如下。 一是完善药品研制和注册制度。支持以临床价值为导向的药品研制和创新,鼓励研究和创制新药,支持 新药临床推广和使用。明确药物非临床安全性评价研究机构资格认定程序,细化药物临床试验 ...
21健讯Daily | 国药控股与贝达药业达成战略合作;遵义市第一人民医院副院长被查
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-04 14:36
Policy Developments - The State Council approved the revised draft of the Drug Administration Law Implementation Regulations, emphasizing the importance of timely revisions to drug management laws for ensuring public safety and promoting the healthy development of the pharmaceutical industry [1] Industry Initiatives - Hainan Province aims to develop over six distinctive traditional Chinese medicine health tourism routes by the end of 2028, with a target of cultivating over 1 million mu of medicinal herb planting and breeding areas, and achieving a 15% growth in the overall output value of traditional Chinese medicine [2] Drug and Medical Device Approvals - Xingqi Eye Medicine announced the approval of its atropine sulfate eye drops for children aged 6 to 12, with new product specifications added [1] Capital Market Activities - Sinovac Biotech has repurchased approximately 1.32 million shares, accounting for 0.66% of its total share capital, with a total expenditure of approximately RMB 49.24 million [3] - Dongcheng Pharmaceutical plans to repurchase shares worth between RMB 100 million and RMB 200 million for employee stock ownership plans, with a maximum repurchase price of RMB 18.00 per share [4] - Haizheng Pharmaceutical's major shareholder intends to transfer 6.06% of the company's shares through a public solicitation, pending approval from relevant authorities [5] Strategic Collaborations - Sinopharm Holdings and Betta Pharmaceuticals have signed a strategic cooperation agreement to enhance collaboration and create a new efficient pharmaceutical supply chain ecosystem [6] Personnel Changes - The independent director of Nanxin Pharmaceutical, Shen Yunqiao, has resigned for personal reasons, and will continue to fulfill his duties until a new independent director is elected [7]
李强主持召开国务院常务会议,审议通过《供水条例(草案)》和《中华人民共和国药品管理法实施条例(修订草案)》
Xin Lang Cai Jing· 2025-12-31 16:01
Group 1 - The State Council, led by Li Qiang, held a meeting to review and approve the draft of the Water Supply Regulations and the revised draft of the Implementation Regulations of the Drug Administration Law of the People's Republic of China [1]