ICH GCP E6 (R3) draft

29-05-2023 / / Legislation

After it was issued almost 30 years ago and several minor additions were made in 2016, the revised guideline of ICH gCP E6 (R3) has been endorsed by ICH Expert Working Group on 19th May 2023. The draft document is available for…

Clinical Trials Regulation and the Clinical Trials Information System (CTIS) EMEA webinar

19-12-2021 / / Legislation

If you have missed the EMA webiner from 29NOV2021 regarding the upcoming CTIS, there is still a chance to acces the slides on EMA wesbite, here.

The scope of the webinar was to inform pharmaceutical companies and academic sponsors of clinical…

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

16-09-2020 / / 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…

Report on clinical trials transparency in The Netherlands

27-08-2020 / / 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 / / 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…