transition challenges for collaboration agreement of drug regulatory ...

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-