Overview of the European Medicines Agency's development of product-specific bioequivalence guidelines

The authors thank the observers of the PKWP who have supported the development of the PSBGL and also Efthymios Manolis, Quirine Fillekes, and Milton Bonelli for constructive comments. Pharmacokinetics Working Party: Ridha Belaiba (ANSM, France); Eva-Gil Berglund (MPA, Sweden); Susan Cole (MHRA, UK); Alfredo García-Arieta (AEMPS, Spain); Sotiris Michaleas (Ministry of Health Pharmaceutical Services, Cyprus); Janet Mifsud (Medicines Authority, Malta); Jan Neuhauser (AGES, Austria); Henrike Potthast (BfArM, Germany); Carolien Versantvoort (MEB, The Netherlands).The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided.peer-reviewe