EFPIA calls for uniform application of pharmacovigilance reforms

The European Federation of Pharmaceutical Industries Associations (EFPIA) has called for uniform implementation of European Union pharmacovigilance reforms proposed by the European Commission.

EFPIA said a common response from member states "will be absolutely critical if the desired end-point is to be achieved". It raised fears based on past experiences of other EU pharmaceutical legislation that "there may be an imposition of additional national requirements such as continued direct electronic submission of safety reports..or individual requests for descriptions of the pharmacovigilance system..."

"This will not be acceptable, as future local deviation merely replicates the complex, duplicative and unharmonised situation that already exists," the federation said. A single pharmacovigilance submission to Eudravigilance alone throughout all member states and a single pharmacovigilance master file "will therefore be crucial or any benefit will be completely obviated".

In a Commission summary of other responses to a round of public consultation, Brussels said there was "strong objection to a proposal to replace the current exceptional circumstances. marketing authorisation with one for intensively monitored. products.

Some respondents felt that having exceptional circumstances marketing authorisations were useful when non-pharmacovigilance issues overrode standard safety concerns. Others "understood the proposal to be a lowering of the standard for placing a product on the market," said the Commission.

Generally, however, there was "strong support for improving the robustness of EU pharmacovigilance with clear legal provisions and better use of resources" by scrapping "duplicative administrative requirements".

A proposal to create a new EU pharmacovigilance committee with a clear legal identity and defined remit was almost unanimously supported.