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公布修订后的《中华人民共和国药品管理法实施条例》
Xin Lang Cai Jing· 2026-01-27 22:09
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。 四是严格药品安全监管。明确药品安全监督检查措施。细化药品质量抽查检验流程,规定当事人对检验 结果有异议的,可以申请复验。针对违法行为设定了严格的法律责任。 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。 新华社北京1月27日电 国务院总理李强日前签署国务院令,公布修订后的《中华人民共和国药品管理法 实施条例》(以下简称《条例》),自2026年5月15日起施行。《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,细化药物临床试验管理要 求。设立药品上市注册加快程序,明确药品再注册程序,规定处方 ...
山西持续加强麻精药品生产监管,防止流入非法渠道
Zhong Guo Fa Zhan Wang· 2025-06-25 10:32
Group 1 - The core viewpoint emphasizes the importance of strict supervision and management of narcotic and psychotropic drugs to prevent illegal distribution [1][2][3] - The provincial drug regulatory authority is enhancing the review of production demand plans and increasing inspections of key drug varieties [2][3] - There is a focus on establishing a comprehensive safety management system for special drugs within enterprises [2][3] Group 2 - The "Clear Source and Cut Off - 2025" initiative aims to include designated enterprises dealing with narcotic and psychotropic drugs in the annual inspection list [3] - Joint efforts with the provincial health commission are being made to ensure compliance in the handling of fentanyl-related products [3] - The province has not experienced any incidents of narcotic drug leakage in recent years [3] Group 3 - Extensive training and educational campaigns are being conducted to raise awareness about new regulations regarding narcotic drug management [4] - Enterprises are targeted as key areas for education, with on-site training for employees on drug abuse management and legal regulations [4] - The use of themed promotional activities, such as Drug Safety Awareness Week and International Day Against Drug Abuse, aims to enhance public awareness and community cooperation [4]
中航证券:带量采购背景下具优势企业受益 建议继续围绕创新药、高端医疗器械等布局
智通财经网· 2025-05-21 02:05
Core Viewpoint - The report from Zhonghang Securities indicates that the pharmaceutical and biotechnology industry is expected to benefit in the long term from ongoing bulk procurement of drugs and medical supplies, with a focus on innovative drugs and high-end medical devices [1][6]. Industry Overview - In 2024, the pharmaceutical and biotechnology industry is projected to achieve operating revenue of 24,657.41 billion yuan, a year-on-year decline of 0.97% [1]. - The net profit attributable to the parent company is expected to be 1,405.71 billion yuan, down 12.97% year-on-year, showing improvement compared to the 2023 growth rate of -18.90% [1]. - The largest revenue segments in 2024 are expected to be pharmaceutical commerce (10,179.60 billion yuan), chemical preparations (4,472.88 billion yuan), and traditional Chinese medicine (3,539.45 billion yuan) [1]. Subsector Performance - In 2024, the chemical pharmaceutical, medical device, and pharmaceutical commerce sectors are expected to see positive revenue growth rates of 4.20%, 1.41%, and 0.78% respectively [2]. - The chemical preparation segment is projected to grow by 4.43%, while the medical device segment is expected to see an 8.40% increase in medical consumables [2]. - Conversely, the vaccine sector is anticipated to decline by 37.77% due to high base effects from previous public health events [2]. Profitability Metrics - The gross margin for the pharmaceutical and biotechnology industry in 2024 is expected to be 32.58%, a decrease of 0.53 percentage points from 2023 [4]. - The net profit margin is projected to be 5.99%, down 0.77 percentage points from the previous year [4]. - The sales expense ratio has been steadily declining, from 17.07% in 2018 to 13.33% in 2024, influenced by centralized procurement and medical insurance negotiations [4][5]. Innovation and Policy Support - The government has reinforced the strategic importance of innovative drugs through various policy measures, including the "Implementation of Innovative Drug Industry Promotion Project" and the establishment of an innovative drug catalog system [6][7]. - The domestic innovative drug sector is becoming increasingly competitive, with the highest number of innovative drug research pipelines globally and a rapid increase in clinical trial numbers [6][7]. - The report highlights that high-quality innovative drug companies are entering a profitability cycle, supported by improved research and development capabilities [7].