药品注册申请数据造假入刑的法理评析

发布时间：2018-10-29 22:24

【摘要】：药品注册申请数据造假违背临床试验的职业伦理和败坏行业风气,容易导致大量劣效、无效药品流入市场,阻碍我国新药研发和创造,影响药品企业的创新和长远发展,影响药品质量安全和药品监管权威,严重威胁人民群众身体健康和生命安全。药品注册申请数据造假入刑具有必要性和正当性。最高人民法院颁布的相关刑事司法解释以严刑峻法回应新药审批治理和社会大众的需求,凸显了司法机关积极为人民生命健康安全保驾护航的司法理念。药品注册申请数据造假入刑,需要一系列配套政策和制度的完善。
[Abstract]:Falsification of data on drug registration applications violates the professional ethics of clinical trials and spoils the industry ethos, which easily leads to a large number of bad effects and ineffective drugs flowing into the market, hinders the development and creation of new drugs in China, and affects the innovation and long-term development of pharmaceutical enterprises. Affecting the quality and safety of drugs and the authority of drug supervision and control, the health and life safety of the people are seriously threatened. It is necessary and legitimate to falsify the data of drug registration application. The relevant criminal judicial interpretation issued by the Supreme people's Court responds to the needs of the new drug examination and approval and the public with the severe punishment law, which highlights the judicial idea that the judicial organs actively protect the health and safety of the people. It is necessary to perfect a series of supporting policies and systems for drug registration data fraud.
【作者单位】：清华大学法学院;中国卫生法学会;中国法理学研究会;
【基金】：教育部2014年哲学社会科学研究重大课题攻关项目“基本医疗服务保障法治化研究”(14JZD025)的阶段性成果
【分类号】：D924.3

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