6月5日，国家药监局官网发布《国家药监局、财政部、市场监管总局关于对药品医疗器械质量安全内部 举报人举报实施奖励的公告》（以下简称《公告》）。 《公告》提出，内部举报人获得举报奖励应当同时符合下列条件：有明确的被举报对象和具体违法事实 或者违法犯罪线索，并提供了关键证据；举报事项事先未被药品监督管理部门掌握；举报事项经药品监 督管理部门查处结案并被行政处罚，或者依法移送司法机关被追究刑事责任。 《公告》规定，相关办法适用于药品、医疗器械生产使用单位，及第三方平台的内部员工、相关知情人 向药品监督管理部门实名举报药品、医疗器械质量安全重大违法行为。根据国家药监局同期发布的政策 解读，此项政策出台背景为，药品医疗器械具有信赖品的特征，群众难以在消费前和消费中通过一般识 别了解其质量问题。与一般举报相比，内部举报具有信息详实准确、专业性强、可信度高等特点，立案 比例高、查实比例高，发现重大风险隐患的可能性大。 为进一步鼓励内部举报人举报药品医疗器械质量安全问题，推动药品医疗器械质量安全社会共治、防范 遏制药品医疗器械领域重大违法行为，国家药监局在深入调查研究、广泛听取意见的基础上，根据《市 场监管领域重大违法行为举 ...

Policy Developments - The National Healthcare Security Administration has revised the medical price and procurement credit evaluation system to combat commercial bribery and encourage integrity among pharmaceutical companies [2][3] - The revised system aims to increase the cost of dishonesty for companies and promote compliance, quality improvement, and effective market participation through collective procurement and national negotiations [2][3] Industry Updates - The internal whistleblower reward system for drug and medical device quality safety has been announced, incentivizing individuals who provide clear evidence of violations that lead to administrative penalties or criminal prosecution [4] - A notification has been issued to promote pain relief services during childbirth across various medical institutions, with goals set for 2025 and 2027 to ensure comprehensive service availability [5] Company News - Puluo Pharmaceutical has received approval for the listing application of Succinic Acid Desvenlafaxine, a third-generation antidepressant for treating major depressive disorder [7] - China Pharmaceutical has obtained a drug registration certificate for Sulfhydryl Clopidogrel Tablets, aimed at secondary prevention of atherosclerotic thromboembolic events in specific patient groups [8] - Shanghai Sipurei Pharmaceutical Technology has completed over 200 million RMB in angel round financing, with funds allocated for preclinical and early clinical development [11] - Kelun Pharmaceutical's subsidiary plans to raise approximately 1.943 billion HKD through a share placement to support product development and operational needs [12] - Merck KGaA has entered a strategic partnership with Zai Lab to commercialize a recombinant human thyroid-stimulating hormone in mainland China [14] - China National Pharmaceutical Group has established a technology innovation research institute with a registered capital of 1 billion RMB, focusing on various research and development activities [15] Management Changes - Tongrentang Technology announced the resignation of its chairman and general manager due to work changes, indicating potential shifts in company leadership [17]

国家药监局、财政部、市场监管总局发布《关于对药品医疗器械质量安全内部举报人举报实施奖励的公 告》。其中提出，内部举报人获得举报奖励应当同时符合下列条件：（一）有明确的被举报对象和具体 违法事实或者违法犯罪线索，并提供了关键证据；（二）举报事项事先未被药品监督管理部门掌握； （三）举报事项经药品监督管理部门查处结案并被行政处罚，或者依法移送司法机关被追究刑事责任。 国家药监局 财政部 市场监管总局 关于对药品医疗器械质量安全内部举报人举报实施奖励的公告 （2025年第41号） 为进一步发挥药品医疗器械产业链质量安全内部监督作用，及时发现和控制药品医疗器械安全风险，根 据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》《医疗器械监督管理条例》《市场监 管领域重大违法行为举报奖励暂行办法》（国市监稽规〔2021〕4号，以下简称《办法》）等规定，现 就药品医疗器械质量安全内部举报人举报奖励有关事项公告如下。 一、药品医疗器械研制、生产、经营企业和使用单位，药品医疗器械网络交易第三方平台提供者以及其 他组织（以下统称企业及相关单位）的内部员工、相关知情人，向药品监督管理部门实名举报药品医疗 器械质量安全重大违法 ...