Advantages of Conducting Clinical Trials in Bulgaria (1995–2009)

ABSTRACT

Worldwide, clinical trials are conducted in accordance with the principles of the Good Clinical Practice (GCP) as described in the Guidelines approved by ICH (International Conference on Harmonization), and in the European Union according to the implemented Directive 2001/20/EC.

Analyses showed that of all clinical trials, from October 2005 to November 2007, 5127 performed in 126 980 centres: 50.6% were conducted in USA and Canada, 27.5% in Europe and 21.9% in the rest of the world.

Reforms in the field of healthcare and the legislation concerning clinical trials in Bulgaria resulted in a considerable increase in the significance of Bulgaria as a partner in multinational clinical trials over the last 10 years. Directive 2001/20/EC, which was officially introduced in Bulgaria in 2007, ensured a regulatory environment for conducting clinical trials to safeguard study subjects without hampering the development of needed drugs.

By the enforcement of the pharmaceutical Drug Law in 1995, the number of clinical trials in Bulgaria gradually increased to 175 (52%) in 2006 compared to 1999. This confirms that the regulatory environment in Bulgaria prior to its accession to the EU has improved, namely, after implementation of the guideline of Good Clinical Practice (GCP) of ICH from the beginning of 2001. Upon the entry of Bulgaria to the EU in 2007 the Directive 2001/20/EC was introduced in the new Law of Medicinal Product in Human Medicine and in the sub Regulation 31 of the Ministry of Health from April 2007.

The purpose of this article is to present and analyse chronologically the regulatory environment for clinical trials, the procedures for issuing authorization for them from the enforcement of the Law on the Drugs and Pharmacies in Human Medicine (LDPHM) since 1995 to 2009 in Bulgaria, as well as the current EU processes in this field.