Dr T. Paal, Hungary

The drug regulatory authorities of the Central and Eastern European Countries (CEEC), the European Union (EU) Commission, and industry met in October 1995 in Brussels to discuss strategies for possible collaboration. As a follow-up to this initiative, a meeting of European heads of regulatory authorities was held by WHO prior to the Eighth International Conference of Drug Regulatory Authorities in Bahrain in June 1996 where initial ideas and reservations were discussed. This was later followed by informal discussions among certain Eastern European countries, regulatory heads, the European Agency for the Evaluation of Medicines (EMEA), and the European Commission.

The first meeting of regulators of the Central and Eastern European countries (CEEC) was held in June 1997 in Sofia, Bulgaria, where a Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries (CADREAC) was drafted. Whereas other collaborating agencies seek to facilitate international movement of goods (manpower, finance, etc), CADREAC seeks to enhance access to and representation in EU internal collaboration. The purpose of this agreement is to enable members to help each other and to facilitate EU principles and requirements. Through such action, a better environment for EU involvement is created, including mutual recognition of regulatory action to avoid unnecessary duplication. Creation of such a forum is expected to enhance coordination.

CADREAC was set up based on the concept of free decision making, with no binding laws or legal obligations. All regulatory authorities are considered equal. Tasks were distributed on a voluntary ad hoc basis. However, it was soon agreed that some of the fundamental activities and principles needed modification in order to make better use of time and expertise and balance the expenses involved. This led to the establishment of a procedure whereby the regulatory authority hosting the Annual Meeting (Assembly) would act as CADREAC Secretariat during the calendar year. It was also decided that any ad hoc duty representation would be “on behalf of CADREAC”, and that information would be available to all parties, even in the event of no direct participation. Other decisions included setting up a governing body of signatories.

The Assembly may be convened once a year by any signatory, by telephone, fax, e-mail conferencing, or other means. A quorum is required, and regulatory authorities which cannot be represented must be advised of the Proceedings. The Chairperson for the Assembly must function exclusively to facilitate its work, and decisions must be taken only by consensus rather than voting. Decisions of the Assembly may not be ignored, but regulatory authorities may decide to apply them individually.