Background
The European Medicines Agency has a risk-management strategy to enhance the planning and implementation of pharmacovigilance and risk-minimization activities for new drugs. This system often requires additional postmarketing pharmacovigilance activities.
Objective
Our objective was to investigate safety concerns for products approved since the EU pharmacovigilance legislation took effect and to analyze associations between these safety concerns and the additional pharmacovigilance activities required.
Methods
We studied 49 new active substances approved in 2013 and 2014 in the EU. For these products, we extracted information from the European Public Assessment Reports on their characteristics, safety concerns, and additional pharmacovigilance activities and analyzed the associations between them.
Results
The 49 products involved 813 safety concerns, 418 of which were subject to additional pharmacovigilance activities, which were implemented for 57.5% of the potential and 38.8% of the identified risks. These additional pharmacovigilance activities included 143 clinical trials (47.7%), 73 non-interventional studies (24.3%), and 72 non-clinical studies (24.0%).
Conclusions
Our results suggest that both the type of additional pharmacovigilance activity required and whether or not they are implemented depend on the product characteristics and their related safety concerns. From the early stages of drug development, companies should consider the kind of safety information that will be required in the postmarketing stage based on what is already known about the product characteristics and anticipated safety concerns.