Abstract
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.
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References
Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries, June 14, 1997, Sofia, Bulgaria.
European Commission. Procedure on the Granting of Marketing Authorization by Central and East European Countries for Medicinal Products for Human Use Authorized in the European Union Following the Centralized Procedure and the Variations and Renewal of such Marketing Authorizations. http://pharmacos.eudra.com.
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Revised Version of the Bulgarian Medicinal Act. State Gazette. Bulgarian National Assembly: February 4, 2000.
Regulation No. 14 of the Conditions and the Order for Conducting Clinical Trials of Drugs on Human Subjects. State Gazette. July 31, 2000.
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Borissov, B.N., Popova, M.J. & Koulaksazova, R.A. Transition Challenges for Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries: Focus on Bulgaria. Ther Innov Regul Sci 35, 935–939 (2001). https://doi.org/10.1177/009286150103500332
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DOI: https://doi.org/10.1177/009286150103500332