Държавно регулиране на клиничните изпитвания на лекарствени продукти
State regulation of clinical trials of medicinal products

Author(s): Radoslav Ivanov
Subject(s): Law, Constitution, Jurisprudence, Human Rights and Humanitarian Law, Commercial Law
Published by: Университет за национално и световно стопанство (УНСС)
Keywords: clinical trials; medicines; history; origin; state regulation; permission
Summary/Abstract: This report analyzes the nature of clinical trials of medicinal products. Traced their origin from VI-V century BC. and their evolutionary development. Two of the greatest tragedies in human history are described – the use of ethylene glycol in the United States and the thalidomide crisis in Europe as catalysts for the understanding that the drug, in addition to a tangible form of treatment, can be an extremely dangerous tool. the State of drug regulation.

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