IRIS, new online platform for scientific advice

13-10-2020 / Daniela van 't Ent - Ifrim / Branche

Starting with 19th of October 2020, Marketing Authorization Holders of human and veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform in order to request scientific advice regarding the study design. 

The following type information may be requested via IRIS:

  • human medicines:
    • Initial and…

UK as first country intending to have 100% of all clinical trials registered and their results reported in the public databse

16-09-2020 / Daniela van 't Ent - Ifrim / Legislation

UK’s Health Research Authority new initiative is to reach 100% of clinical trials registration, including CT results, into the public database. This is in order to offer transparency regarding clinical trials and facilitate information sharing among the researchers.

This strategy:

  • is based…

MHRA Guidance regarding Brexit for industry and organisations to follow from 1 January 2021

03-09-2020 / Daniela van 't Ent - Ifrim / Branche

MHRA has just issued guidance regarding post Brexit period and clinical trials, devices, licensing, importing and exporting, IT systems, pharmacovigilance and paediatrics.

Report on clinical trials transparency in The Netherlands

27-08-2020 / Daniela van 't Ent - Ifrim / Legislation

TranspariMED and Health Action International (HAI) have recently reported that Dutch institutions that run clinical trials violate the European transparency rules but failing to report clinical trials results in the public registry.

Only 1 out of 23 universities/research institutes has adequately…

First EMA newsteller regarding the Clinical Trials Information System (CTIS)

14-07-2020 / Daniela van 't Ent - Ifrim / Legislation

EMA board has announced that the implementation of the Clinical Trials Information system (CTIS) would be December 2021. The CTIS is the portal for the Clinical Trials Regulation 536/2014. 

Recently, EMA has released the first newsletter on the topic which gives…