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transition challenges for collaboration agreement of drug regulatory ...

transition challenges for collaboration agreement of drug regulatory ...

938 Borislav N.

938 Borislav N. Borissov, Maria J. Popova, and Rozalina A. Koulaksazova FIGURE 1. Clinical trials conducted in Bulgaria between 1995 and 2000. THE NATIONAL INFORMATION • Optic archive of packages, and SYSTEM ON PHARMACEUTICALS • Information technology. An important responsibility of the Bulgarian The agency’s Web site (www.bdg.bg/ Drug Agency is to maintain a national infor- bulletin) includes all registered drugs, mation system on pharmaceuticals. An Ora- searchable by trade name, international non- cle-based drug database was established in proprietary name, Anatomical Therapeutic 1998, comprising nine modules covering ar- Chemical (ATC) code, and manufacturer. eas of activity within the agency: The site also contains lists of over-the- counter drugs and licensed wholesalers with • Marketing authorization, essential information on their licenses, and • Manufacturing authorization, information on current information recalls. • Wholesaling authorization, Basic registration and sales statistics are pub- • Import and sales, lished annually. The top 50 ethical and over- • Medicinal products advertising, the-counter products are listed by number of • Adverse drug reactions register, packs and revenue. The Web site is updated • Medical devices, weekly. FIGURE 2. Phase II and III clinical trials conducted in Bulgaria between 1995 and 2000.

Challenges for Eastern European Associated EU Countries: Bulgaria 939 The agency publishes three quarterly bul- Forum on Pharmaceuticals is another impor- letins for prescribers and retail pharmacists: tant form of partnership between regulators Newly Registered Drugs Bulletin, Bulletin on on an international basis. These collabora- Adverse Drug Reactions, and Specialized tions that CADREAC takes part in play an Drug Bulletin. The guiding principal of important role in bridging the gaps and build- Specialized Drug Bulletin is to classify auing a common network of competence, confithorized medicinal products according to the dence, and credibility in pharmaceutical reg- internationally accepted classification, allowing comparisons among countries; this is ulation. the philosophy of the International Society of Drug Independent Bulletins. The analysis REFERENCES of drug consumption based on the ATC/defined daily dose methodology became an im- 1. Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries, portant tool for determining trends in the pre- June 14, 1997, Sofia, Bulgaria. scribing profile and for starting a national 2. European Commission. Procedure on the Granting of dialogue on rational and cost-effective drug use. Marketing Authorization by Central and East Euro- pean Countries for Medicinal Products for Human Use Authorized in the European Union Following the Centralized Procedure and the Variations and Re- CONCLUSION newal of such Marketing Authorizations. http://phar macos.eudra.com. The implementation of EU standards in CADREAC is a consequence of the effort 3. Organization of a Pan European Regulatory Forum on Pharmaceuticals. Terms of Reference, PRAQIII. Pan European Regulatory Forum on Pharmaceuticals. of all countries and their drug regulatory http://perf.eudra.org. authorities, and collaborative activity among 4. Revised Version of the Bulgarian Medicinal Act. State CADREAC countries. Essential support from the EU—both financial and professional—has also had a positive impact on Gazette. Bulgarian National Assembly: February 4, 2000. 5. Regulation No. 14 of the Conditions and the Order for Conducting Clinical Trials of Drugs on Human this process. The Pan European Regulatory Subjects. State Gazette. July 31, 2000.

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