Collaborative Agreement of Drug Regulatory

CADREAC, Collaborative agreement of drug regulatory authorities of EU associated coimtries, http //www.cadreac.org, accessed on June 10, 2002. 

Dr. Mircheva was instrumental in the passing of the first Medicines Law of 1995 and initiated Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries (CADREAC). She has been a visiting scientist in Germany and is a member of a number of scientific societies and on the editorial boards of scientific and regulatory journals. 

For submissions involving medical devices and/or drugs that are not clearly addressed in this agreement, sponsors are referred to the product jurisdiction regulations (21 CFR Part 3). These regulations have been promulgated to facilitate the determination of regulatory jurisdiction but do not exclude the possibility for a collaborative review between the centers. 

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