Comparison of European Medicines Agency (EMA) and Food and Drug Administration (FDA) procedures for evaluating scientific and regulatory issues of clinical studies during the development of medicinal products: Experience

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

K. Ludajic and J. Hicks

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Here we compare the procedures for obtaining pre-approval for the Clinical Study Protocols and accompanying documentation by two regulatory agencies - European Medicines Agency (EMA) and Food and Drug Administration (FDA). The procedures called Scientific Advice and Protocol Assistance (SA/PA), and Special Protocol Assessment (SPA), respectively, are compared in terms of duration, scope, cost and possible outcomes. In addition, we discuss the reasons why our clients submitted more than fifty Independent Review Charters (IRC, a document which governs the independent review process) as accompanying material for SPA to FDA, and to our knowledge none for SA/PA to EMA. Research of publicly available documents and company-wide investigation showed that the two procedures are similar in design and purpose. If the sponsor and the agency agree on the design, execution and analyses proposed in the submitted documentation, the agreement becomes part of the administrative record. The agreement is not legally binding on either of the Agencies; however, complying with the agreement significantly shortens the duration of the marketing authorization applications and increases its success. Our data show that pre-approval procedures, if employed, offer a clear benefit to clients; therefore they should be explained and recommended to all clients targeting global markets.

Biography :

Katarina Ludajic is a Senior Medical Writer at Perceptive Informatics. She earned a B.S. in Biology at the University of Belgrade, Serbia and Ph.D. in Molecular Biology at the Friedrich-Schiller University in Jena, Germany. She has completed her post-doctoral training at the General Hospital of Vienna, Austria where she performed research in the field of Transplantation Biology. She is the first author on multiple scientific articles published in peer-reviewed journals.