ARTICLE | Politics & Policy

EU clarifies law on postmarket trials

April 12, 2014 12:00 AM UTC

The European Commission adopted a delegated act that specifies limited circumstances under which EMA can require a postmarketing efficacy trial. EMA can require postmarketing efficacy when the initial efficacy assessment was based on surrogate endpoints, or to resolve uncertainties about combination therapies or patient subpopulations. EMA also can require postmarketing efficacy trials if a potential lack of long-term efficacy raises concerns about benefit-risk balance, or if benefits are "significantly affected" by real-world use. Lastly, EMA may require a postmarketing efficacy trial if standard of care changes, or if pharmacology or "new concrete and objective scientific factors" may require previous efficacy evaluations to "be revised significantly."

The act clarifies pharmacovigilance legislation implemented in the EU in 2012, which allowed EMA to require postmarketing efficacy trials when changes in disease understanding or clinical methodology "indicate that previous efficacy evaluations might have to be revised significantly," and when efficacy concerns could only be resolved after a product is marketed. ...