News

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…

CCMO presents Annual Report 2016

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

The protection of human subjects involved in clinical research represents this year's main topic in the annual report from the CCMO.

In this report CCMO explains its view on the role and importance of human subjects involved in medical research. The…

EMA possible new guideline on Quality requirements of medicinal products

16-03-2017 / Daniela van 't Ent - Ifrim / Legislation

European Medicines Agency has publsihed a concept paper regarding developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal products. The draft article has first been published on 16th of…

Dutch Government wants European Medicines Agency to relocate to the Netherlands

25-02-2017 / Daniela van 't Ent - Ifrim / Branche

The Netherlands has applied to host the European Medicines Agency (EMA) which is based curently in London. However, EMA will need to relocate to another European country when the United Kingdom leaves the EU. Health minister Edith Schippers and foreign…

Regulatory Science Magazine (College ter Beoordeling van Geneesmiddelen)

25-02-2017 / Daniela van 't Ent - Ifrim / Branche

College ter Beoordeling van Geneesmiddelen (CBG) launched during the Science day the Regulatory Science Magazine. The magazine appears 4 times per year and contains different articles with regard to safety use of the medicinal drugs as well as legislational matters.