Recent Changes in Clinical Trial Authorization in Eastern Europe
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0092-86 15/97 Copyright 0 1997 Drug Information Association Inc.
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RECENT CHANGES IN CLINICAL TRIAL AUTHORIZATION IN EASTERN EUROPE TAMASL. PAAL Director-General, National Institute of Pharmacy, and Head, Department of Pharmacy, “Haynal Imre” University of Health Sciences, Budapest, Hungary
The aim of the present work was to discuss, from the regulatory point of view, the recent developments in clinical trial authorization in Eastern European countries. The study was based on a questionnaire sent to drug regulatory agencies or clinical experts in 12 countries as well as on the author’s personal experiences. Very fast changes in ethical approval, good clinial practice (GCP) application, and its compliance monitoring could be observed, especially in countries associated with the European Union. The impact of the newly accepted International Conference on Hamonization GCP is also likely in Eastern Europe. Key Words: Clinical trials; Ethical approval; Eastern Europe; Good clinical practice
INTRODUCTION THE AIM OF THE present work was, admittedly from a regulator’s point of view, to analyze the recent changes in clinical trial authorizations and supervisions in Eastern European countries. In order to obtain up-todate information, a questionnaire was sent to 12 countries covering drug regulatory agencies and clinical experts. Answers were received from 10 countries. The author’s personal experience provided background for discussion of the situation in countries which did not answer, or were not sent, the questionnaire. Special emphasis was given to the application of good clinical practice. This discussion of Eastern European drug affairs will provide a short overview, trends,
Based on a presentation at the DIA 32nd Annual Meeting ‘The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,’’ June 9-13, San Dicgo, California. Reprint address: Prof. Tamb L. Pail. National Institute of Pharmacy, Budapest 5 , P.O. Box 450, H-1372 Hungary.
and historical background. Before starting the discussion, however, “Eastern Europe” should be defined. In this paper, the view of the Regional Office for Europe of the World Health Organization (WHO) is accepted. In WHO’Sopinion, Eastern Europe also covers, in addition to “geographical Europe,” the former Soviet Central Asian countries where WHO has been active for many years. Thus, according to WHO terminology, “Central and Eastern European countries plus the Newly Independent States” (CEECNIS) includes all non-European Union and nonEuropean Free Trade Association (EFTA) countries except Israel and Turkey. This paper uses CEECNIS for Eastern Europe. Speaking about GCP, however, facilitates this issue considerably, since, at present, it is not applied in the Central Asian former Soviet Republics yet.
HISTORICAL BACKGROUND The target countries never belonged to a homogenous Eastern Bloc (1). First, there was the Council of Mutual Economic Assistance
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