The Council has adopted the ‘pharma package’, a new set of rules that will increase patients’ access to medicine and make the EU’s pharmaceutical sector fairer and more competitive. The package represents a far-reaching reform of the EU’s pharmaceutical...

The present document provides CT sponsors with the operational guidance they need to submit ASRs through the New Safety Module on ASR, including responding to the relevant Requests for Information (RFI). It is foreseen that this module will be integrated in the...

É com grande satisfação que anunciamos que a Formiventos é, pelo quinto ano consecutivo,  empresa certificada TOP 5% MELHORES PME PORTUGAL, edição de 2026, certificação atribuída pela SCORING, em termos de desempenho e solidez financeira.  Este feito é motivo de...

This guidance describes the technical standards associated with preparation of the electronic  submission template for PMAs/PMA supplements that enable submission of the Designated  Application Types solely in electronic format. This does not include PMA Modules and...