EFPIA calls for more robust rules on pharmacovigilance studies
BPI said a law would serve the interest of public health and regulatory clarity
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on the European Union (EU) to solidify rules for staging post-authorisation efficacy studies, saying the pharma industry needs more clarity on when they are held and their potential consequences.
Commenting on a European Commission consultation paper on such pharmacovigilance assessments, the EFPIA called for new legislation. It said: ‘Obtaining clarity and predictability on expectations for when PAES [post-authorisation efficacy studies] may be required and ensuring that PAES are not imposed unnecessarily or inappropriately is highly desirable.’
The EFPIA wants legislation to define PAES and also ‘provide an explicit and clear legal mandate to EU regulators to accept data from studies other than randomised controlled trials’. Moreover, associated non-binding guidance should be issued containing detailed recommendations and design issues for studies.
‘The combination of a delegated act and a scientific guidance should minimise the risk for arbitrary or unpredictable PAES decisions,’ said the EFPIA.
The EFPIA’s views were backed by the German Pharmaceutical Industry Association (BPI), which said a law would serve the ‘interest of public health and regulatory clarity’. The BPI notably wants more advice on when regulators could insist that a post-authorisation study is held as a condition of marketing authorisation.