Читать книгу Clinical Pharmacology and Therapeutics - Группа авторов - Страница 122

Clinical trials form the main basis for determining drug safety and efficacy prior to regulatory approval and must be performed under highly regulated processes in order to minimise the risk to participants. This principle of protecting the rights of the trial subjects comes from the Declaration of Helsinki (initially agreed by the World Medical Association in 1964, with revisions made when needed since). The International Conference on Harmonization (ICH) brings together the regulatory authorities of Europe, Japan and the United States, with the aim of producing common guidelines relating to quality, e.g. manufacturing, safety and efficacy requirements. Their Good Clinical Practice Guidelines were established to provide a unified standard for clinical trials across the three main regulatory authorities maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.