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首页> 外文期刊>Food and Drug Law Journal >The Evolving Regulatory Landscape for Clinical Trials in India
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The Evolving Regulatory Landscape for Clinical Trials in India

机译：印度临床试验的不断发展的监管景观

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Since 2013, India has undergone a significant regulatory transformation in regard to clinical trials. Following controversial media coverage of deaths that were allegedly related to clinical trials, the Indian government attempted to bolster its regulatory framework by releasing a number of new and complex regulations that quickly made India an unpredictable jurisdiction in which to site and conduct clinical trials. This article describes the events and regulatory changes that have shaped India's clinical trial landscape over the past several years. The article ultimately concludes that many of the well-meaning requirements imposed on researchers and sponsors beginning in 2013 chilled the clinical trial environment, yet the requirements also brought appropriate attention to complex ethical issues. While many of the more stringent regulations have since been clarified or withdrawn through the Indian government's continuing reform efforts, the recent India experience demonstrates how regulatory uncertainty can deter advances in clinical research.
机译：自2013年以来，印度在临床试验方面经历了重大的监管转型。涉嫌媒体覆盖据称与临床试验有关的死亡覆盖率，印度政府试图通过释放许多新的和复杂的法规，以迅速使印度迅速成为现场和进行临床试验的不可预测的管辖权。本文介绍了在过去几年中形成了印度临床试验景观的事件和监管变化。这篇文章最终得出结论，即2013年开始研究人员和赞助商对研究人员和赞助商施加的许多良好意义要求冷却临床试验环境，但这些要求也适当地关注复杂的道德问题。虽然许多更严格的法规已经通过印度政府的持续改革努力澄清或撤销，但最近的印度经验表明了监管不确定性如何阻止临床研究的进步。

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