EMA to Follow FDA-Like Practice to Advice on Post-Marketing Study Design
Posted on: Thursday, July 23, 2015

Since 2011, FDA has required many sponsors of newly approved drugs to conduct mandatory post-marketing safety studies. These studies could be required as a post-marketing commitment before a drug can be approved or if a new safety concern is raised after the product becomes available in the US market. FDA also advises the manufacturers about the design of these studies and requires mandatory reporting of the results. However, in Europe, post-authorization safety studies (PASS) could be either mandatory, or voluntary. For mandatory PASS, which are required before the product can be approved; the manufacturer needs to seek advice from the Pharmacovigilance Risk Assessment Committee (PRAC). For non-mandatory studies, however, there was no process to ask the regulators for appropriate design of the trial. Starting July 2015, EMA launched a 12-month pilot program for providing advice regarding the non-mandatory PASS whereby companies can approach EMA to get agreement on acceptable post-marketing trial design. This is another case of harmonization of regulatory practices across US FDA and EMA.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research