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936 Borislav N. Borissov, Maria J. Popova, and Rozalina A. Koulaksazova • The European Union Associated Countries procedure for centralized authorized prod- of Central and Eastern Europe meeting on ucts (2). This procedure, a serious step in the pharmaceutical issues in Brussels on Octo- preparation for EU accession, was effective ber 25, 1995, as of January 1, 1999. Under this procedure, • A roundtable of European Union/Central CADREAC countries accept the European and Eastern European countries on the Medicine Evaluation Agency’s (EMEA’s) pharmaceutical industry in Brussels on June evaluation of centrally authorized products 27, 1996, and and issue a decision on granting a marketing • An informal meeting between some Central authorization within 90 days. and Eastern European countries and the Euro- The implementation of the procedure is pean Union in London in December 1996. important for marketing application holders, drug regulatory authorities, and patients. CADREAC was inaugurated during the Marketing application holders benefit from first meeting of the drug regulatory authori- faster access to the market and lower fees. ties of Central and Eastern Europe in Sofia, Drug regulatory authorities benefit from Bulgaria in 1997 (1). Ten countries signed more experience and resource savings. Fi- the agreement: Bulgaria, Czech Republic, nally, patients benefit by fast availability of Estonia, Hungary, Poland, Slovakia, Latvia, innovative products on the market. General Lithuania, Romania, and Slovenia; Cypress registration statistics about centrally authorjoined CADREAC in 1998. Together, these ized products for 1999 and 2000 show the countries represent a significant pharmaceu- contribution of the simplified centralized tical market of more than 100 million people. procedure (Table 1). CADREAC is a voluntary agreement for Another ambitious task of the agreement mutual assistance of the European Union As- is the elaboration of a common simplified sociated Countries. It is supported by Euro- procedure for products subject to the Mutual pean Union (EU) officials and encouraged Recognition Procedure in the EU. For these by the World Health Organization. The key products, CADREAC countries look for a aims of the agreement are to: successful balance between their national responsibilities and European requirements. 1. Enhance implementation of EU standards Participation in the work of the EMEA and requirements, and the Committee for Proprietary Medicinal 2. Create a better environment for EU to in- products is a serious tool for accelerating EU volve Central and Eastern European coun- harmonization. CADREAC is represented by tries, two observers on each topic: quality, efficacy, 3. Facilitate the introduction of mutually rec- safety, Good Manufacturing Practice, Good ognizable procedures, Clinical Practice, Mutual Recognition Facili- 4. Establish a forum to discuss strategies for EU tating Group, information technology, Notice accession (avoiding duplication of work), 5. Organize meetings of Central and Eastern to Applicants, and so forth. European countries’ drug regulatory authorities and between Central and Eastern European countries and the EU, and The Pan European Regulatory Forum on Pharmaceuticals 6. Participate in the European network of regu- The Pan European Regulatory Forum on latory information on medicinal products. Pharmaceuticals develops strategies to meet emerging political and economic changes National Achievements due to the CADREAC Collaboration (3). It is an open, constructive dialogue that analyzes the situation and, at the same time, determines mechanisms for fulfilling techni- One of the major achievements of the collabcal requirements of the white paper, which oration is the elaboration of the simplified outlines the principal requirements govern-
Challenges for Eastern European Associated EU Countries: Bulgaria 937 TABLE 1 Medicinal Products in Bulgaria, Centrally Authorized in the EU Number of Number of Registered Year/Kind of Procedure in Bulgaria Applications Medical Products 1995–98/National Procedure 55 53 1999–2000/Simplified Centralized Procedure 72 56 + 16 in progress ing the preparation for integration to the for products using the national proce- Community Market of the European Comdure,munity Associated Countries. The forum is • Medical devices and in vitro diagnostics funded by the EU project Poland Hungary are included in the scope of the Medici- Albania Romania Estonia (PHARE) and was nal Act. Specific requirements for granting established in 1999. It focuses on the follow- marketing applications of medical devices ing priority action areas: and in vitro diagnostics were stipulated in a separate regulation of August 2000. The 1. Acceptance of European Community trea- requirements of the three relevant Euroties, regulations, decisions, and directives pean directives (93/42, 90/385, and 98/79) by all member states and applicant coun- have been incorporated into national legistries,lation. The Bulgarian Drug Agency is re- 2. Quality, efficacy, safety, sponsible for granting marketing applica- 3. Good Manufacturing Practice, tions for these products. The Conformitee 4. Responsibilities and mandate of the com- Europeene (CE) mark is respected; for petent authorities, and products with the CE mark the procedure 5. Information technology. lasts two months. • An additional point of over-the-counter Interagency training is considered a future sales was established. The revised law aptopic of collaboration for the Pan European proves medicinal product sales in drug Regulatory Forum on Pharmaceuticals. stores, which were established in Bulgaria in 2000. A sublaw regulation with a general sale list was published. The list comprises IMPORTANT REGULATORY a limited number of products from the over- CHANGES IN BULGARIA’S the-counter list including some medical de- PHARMACEUTICAL SECTOR vices and in vitro diagnostics, and DURING 2000 • Conduct of clinical trials. The regulation on clinical trials was amended in Septem- The Medicinal Act of February 2000 revised the 1995 law (4). Several topics that were already harmonized with European legislation were not changed. Others were amended to reach compliance with EU legislation. Some new provisions were introduced. Important new provision in the revised law and sublaw regulations are: ber 2000. Annex 1 is an adopted translation of the International Conference on Harmo- nization tripartite Guideline for Good Clin- ical Practice and Annex 2 is the notification form (5). The duration of this approval procedure is two months for Phases II and III and one month for Phase IV. Detailed information is available on the Bulgarian Drug Agency Web site (www.bda.bg/Doc- • The timeframe for assessment and umentsonMainImportance). Experience in granting of marketing applications was clinical trials is gradually growing (Figures shortened from 12 months to 7 months 1 and 2).
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Page 5: Challenges for Eastern European Ass

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