With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic ...

The implementation process of SPOR over several phases… that’s nothing new. However, after the 6-month delay due to the ...

A combination of factors has resulted in the shifting timeline of EMA’s implementation of the IDMP data collection. One ...

Since January 1st 2016, all Submissions to the European Union have to include electronic application forms instead of ...

EMA eCTD specifications – General Update In October, EMA has officially released the version 3.0 of the European Module ...