Conducting clinical trials in Romania

Romania, a member of the EU, has one of the larger populations in the region, with over 22 million inhabitants. Two million live in Bucharest, the capital, and about 10 million in other cities such as Iasi, Timisoara, Constanta, Cluj-Napoca, and Craiova. These large cities have medical schools which are recognized by the International Directory of Medical Schools. Adults (15+ years of age) comprise 18.5 million of the total population. Almost all the population is literate and all have state-supported medical and psychiatric coverage. As in the rest of the western world, the leading causes of death are cardiovascular disease, cancer, and respiratory disease.

(Source: Population and Statistics Division of the United Nations Secretariat, World Bank World Development Indicators database, The World Heath Report 2008).

Regulatory Procedures and Timelines

In 1997, a year after ICH-GCP guidance was adopted as the unified standard for the EU, the USA and Japan, they became law in Romania.

The EU Clinical Trials Directive of April 4th, 2001, was incorporated into local legislation and published on July 5th, 2004, making Romania one of the first countries in the EU to adopt it as a law. This was followed by a set of laws implementing the Directive 2001/20/EC guidelines (the request for authorization of a clinical trial on a medicinal product for human use, notification of substantial amendments and declaration of the end of the trial, application format and documentation to be submitted to an Ethics Committee; the collection, verification and presentation of AE, GCP inspections, documents archiving).

The regulatory process in Romania is transparent and relatively fast. The submission of the study documents is done in parallel to the local institutions conducting the trial and to the National Medicines Agency and Ethics Commission. For properly submitted documentation, by law the process may not take more than 60 days.

TANGENT DATA “Hands in” Study Management protects from Time Table deviation

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