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药品医疗器械质量安全举报奖励
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国家药监局等三部门发文 奖励药品器械质量问题“吹哨人”
Jing Ji Guan Cha Wang· 2025-06-06 05:16
Group 1 - The core viewpoint of the announcement is to encourage internal whistleblowers to report major violations related to the quality and safety of drugs and medical devices, thereby enhancing regulatory oversight and public trust in these products [1][2] - The announcement specifies that internal whistleblowers must provide clear evidence of violations that have not been previously known to regulatory authorities, and that these reports must lead to administrative penalties or criminal prosecutions [1][2] - The policy aims to leverage the detailed and credible information that internal whistleblowers can provide, which is expected to increase the likelihood of identifying significant risks and violations in the pharmaceutical and medical device sectors [1][2] Group 2 - The reward system for whistleblowers includes a maximum reward of 1 million yuan per case, with the specific amount determined by discussions between the drug supervision department and local government finance departments [3] - The implementation of this policy is part of a broader initiative to promote social governance in drug and medical device quality safety, with the aim of preventing and curbing major illegal activities in the sector [2][3] - Following the announcement, some provincial drug supervision departments have begun to adopt similar policies to encourage internal reporting of violations, indicating a trend towards more robust regulatory frameworks in the industry [3]
健讯Daily 丨国药集团在北京成立科技创新研究院公司;德国默克集团与泽璟制药达成战略合作
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]
三部门:对药品医疗器械质量安全内部举报人举报实施奖励
news flash· 2025-06-05 09:16
Core Viewpoint - The announcement by the National Medical Products Administration, Ministry of Finance, and State Administration for Market Regulation aims to enhance the internal supervision of drug and medical device quality safety by implementing a reward system for internal whistleblowers [2][12]. Group 1: Reward Conditions - Internal whistleblowers must meet specific conditions to qualify for rewards, including having a clear target and evidence of illegal activities, the matter not being previously known to authorities, and the case being resolved with administrative penalties or criminal prosecution [5][6]. - The definition of internal whistleblowers includes current employees, former employees within a year, and individuals with relevant business ties to the organization [3][4]. Group 2: Reporting Mechanism - The drug supervision authorities will maintain open channels for receiving reports, including a dedicated hotline and online platforms, and encourage organizations to display these reporting channels prominently [3][4]. - Upon receiving a report, authorities are required to process it according to established regulations and prioritize investigations into significant violations [4][6]. Group 3: Reward Implementation - Rewards will be determined collectively by the drug supervision department, and can include both monetary and non-monetary recognition [4][7]. - The funding for rewards will be included in the departmental budget and subject to oversight by financial and auditing departments [7][8]. Group 4: Protection of Whistleblowers - Measures will be taken to protect the personal information of whistleblowers, and any retaliation against them by employers will be subject to legal consequences [10][11]. - Organizations are encouraged to establish internal mechanisms for reporting safety risks and to actively promote a culture of safety and compliance [11][12].