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Regulatory Framework for Developing Clinical Trials in Romania

The measure of Romania’s success as a clinical trials destination lies in the rapid evolution of the regulatory framework, which was promptly transposed from EU rules and regulation into national legislation. It has been observed that this regulatory environment was one of the principal reasons why the number of completed and active studies in Romania increased from 75 in 1994 to 214 in 2004, and to 1484 in February 2014 (Fig.2)(4). Mirela Vita and Adina Pirvu of the National Agency for Medicines and Medical Devices, and Cristina Florescu Moraid of Synevo explicate the regulatory framework in Romania, and suggest why the country is becoming such a desirable destination for conducting clinical trials.