Regulatory Modeling and Simulation Moves Into the Next Gear in Europe

Abstract

The increasing pace of investments across academia and industry in the areas of pharmacometrics and systems pharmacology has the potential to profoundly impact drug discovery and development efficiency. In addition, it is being recognized that model-based approaches have also increasingly become important in regulatory decision making.1,2,3 For example, an analysis of 198 new drug application and biological license application submissions, reviewed by the US Food and Drug Administration's Division of Pharmacometrics during the period 2000–2008, suggested an impact of the pharmacometrics analysis on drug approval and labeling decisions in ~65% of the cases. Although the potential for regulatory impact of modeling and simulation (M&S) appears to be shared by regulators across most international agencies, there are marked differences in the implementation of pharmacometric assessments during drug registration.1 For example, to date, the US Food and Drug Administration is the only regulatory agency that has a dedicated Pharmacometrics group, formed within the Office of Clinical Pharmacology in 2009,2 which not only reviews submissions but also conducts its own analyses. It now appears that regulatory M&S moves into the next gear in Europe as well, because in a recent press release, the European Medicines Agency (EMA) announced the creation of a new regulatory M&S working group being effective from the end of January 2013 (http://www.ema.europa.eu/ema/). This announcement builds on the output from a joint EMA and European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on M&S,4 held at the end of 2011, at which representatives from industry, academia, and regulatory agencies discussed the current and future role of M&S in the development and registration of medicinal products. Specifically, one of the actions from the workshop was that the “EMA will aim to increase the regulatory M&S competence in Europe by coordinating the expertise across Member States to provide a consistent approach in product-related and methodology-related discussions,”4 and the recent announcement demonstrates that the European regulators have started to deliver on this commitment. Consistent with the journal's mission to be a “publication platform for Pharmacometrics and Systems Pharmacology that will contribute to further growth of the disciplines and a broader application and better integration of the model-based approaches across the research and development spectrum,”5 the current issue of CPT: Pharmacometrics & Systems Pharmacology contains a full report of the plenary session4 and four breakout sessions6,7,8,9 of the EMA/EFPIA Workshop on M&S, coauthored by a range of discipline leaders from EMA, EFPIA, and European academic centers.