News

EC issues guidance to mitigate clinical trial disruption in the EU

28-04-2020 / Daniela van 't Ent - Ifrim / Legislation

The Commission has published guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic. The aim is to mitigate the disruption of clinical research in Europe and the negative effects of the pandemic, without…

MDR postponed by one year (2021)

28-04-2020 / Daniela van 't Ent - Ifrim / Legislation

The moment of ratification of the European Medical Device Regulation (EU no 2017/745 (MDR)) has been postponed by one year due to the corona crisis. The new date is 26 May 2021.

External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use

17-04-2017 / Daniela van 't Ent - Ifrim / Legislation

The document below provides guidance on practical aspects of the implementation of the Agency's policy on the publication of clinical data for medicinal products for human use.

It covers guidance regarding:

- procedural aspects of the submission of clinical reports,

- the anonymisation of clinical…

Revising the guideline on first-in-human clinical trials

22-03-2017 / Daniela van 't Ent - Ifrim / Legislation

The European Medicines Agency in cooperation with the European Commission and the Member States of the European Union is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants.

This revised guideline aims…