Transition Challenges for Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries:
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
TRANSITION CHALLENGES FOR COLLABORATION AGREEMENT OF DRUG REGULATORY AUTHORITIES IN EUROPEAN UNION ASSOCIATED COUNTRIES: FOCUS ON BULGARIA BORISLAVN. BORISSOV, MD, PHD Executive Director
MARIAJ. POPOVA, MD, PHD Head of Directorate, Drug Information and Pharmacovigilance
ROZALINA A. KOULAKSAZOVA, MSc PHARM Head of Department, Specialized Drug Information Bulgarian Drug Agency, Sofia, Bulgaria
The article focuses on the challenges faced by the Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries (CADREAC) in harmonization with European Union pharmaceutical standards. The beneficial impact of different forms of collaboration and the national acheivements of the Bulgarian Drug Agency are reviewed. In the harmonization process, drug regulatory authorities are dedicated to collaborating with all stakeholders, starting with industry and ending with consumers. Key Words: CADREAC; European Union; Bulgarian Drug Agency; Pan European RegulaHarmonization; Collaboration; Pharmaceutical legislation
tory Forum on Pharmaceuticals;
INTRODUCTION THE COLLABORATION Agreement of Drug Regulatory Authorities in European Union Associated Countries was established in 1997.Participating countries-Bulgaria, Czech Republic, Estonia, Hungary, Poland, Slovakia, Latvia, Lithuania, Romania, and Sloveniashared similar histories and responsibilities and a common goal-the harmonization of drug development. CADREAC provided an informal way to provide mutual assistance in the harmonization process. The Bulgarian Drug Agency’s present priReprint address: Borislav N. Borissov, MD, PhD, Director, Bulgarian Drug Agency, Yank0 Sakazov Blvd., 1504 Sofia, Bulgaria. E-mail: [email protected].
ority is the preparation of the pharmaceutical sector for accession to the European Union. This is an intensive process of harmonization of standards and good practices, introduction of mutually recognizable procedures, and implementation of the acceptance of European Community treaties, regulations, decisions, and directives by all member states and applicant countries.
IMPACT OF INTERNATIONAL FORMS OF COLLABORATION CADREAC Establishment and Philosophy Three meetings were held before CADREAC was established:
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Borislav N. Borissov, Maria J. Popova, and Rozalina A. Koulaksazova
The European Union Associated Countries of Central and Eastern Europe meeting on pharmaceutical issues in Brussels on October 25, 1995, 0 A roundtable of European UniodCentral and Eastern European countries on the pharmaceutical industry in Brussels on June 27, 1996, and 0 An informal meeting between some Central and Eastern European countries and the European Union in London in December 1996. 0
CADREAC was inaugurated during the first meeting of the drug regulatory authorities of Central and Eastern Europe in Sofia, Bulgaria in 1997 (1). Ten countries signed the agreement: Bulgaria, Czech
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