From 23 July 2025, a revised version of Good Clinical Practice (GCP) for clinical trials of medicinal products in humans will apply. The new version of this guideline prepared by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) with the official designation ICH E6 (R3) replaces the previous version (R2). The previously very concise basic principles have been formulated in more detail for the new version of the guideline and now represent the core document of GCP. This is supplemented by annexes that serve to interpret and apply the basic principles. Annex 1, which has already been finalised, focuses on interventional clinical trials. In terms of content, the newly formulated basic principles an Annex 1 replace the previous GCP version (R2). Annex 2 will soon complete the new GCP guideline. It will deal with additional considerations for special study designs, such as decentralised studies, pragmatic studies and studies with real-world data. The new GCP version (R3) is more closely linked to the ICH guidleine E8 (R1) on general considerations for clinical trials.

Presentations and videos of an EMA workshop from February 2025 on the new GCP version (basic principles an Annex 1) can be found here.

Under the motto "Fridays for Future" jung people all around the world campaign for a more vigorous fight against climate change. Likewise, in many German towns pupils and students came out on strike every Friday in order to publicly call attention to their cause.

We at CliPS think that this commitment is admirable und we are delighted to see that numerous scientists have meanwhile gathered under the name of "Scientists for Future" in order to support the pupils and students with scientific arguments. Our own professional discipline - clinical research - is home to countless scientists, many of whom have surely already contemplated the topic of climate change. We would like to ask all our colleagues to catch up on "Fridays for Future" and "Scientists for Future". If you speak German, please watch the video "Aufruf an die Politik" (call on politicians).

We have decided to sign the statment issued by "Scientists for Future" and we would be glad if as many colleagues from our branch of industry as possible could do the same.

The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute (PEI) jointly publish a quarterly drug safety bulletin called
 

You can find the current edition (German only) using this link.

Further news from the higher federal authorities:

It has become increasingly certain that EU Regulation 536/2014 (Clinical Trials Regulation) will finally come into effect in 2022. This regulation will mainly harmonize the procedures for obtaining approvals for the conduct of clinical trials with medicinal products in the EU. In order to prepare physicians (investigators) working in such clinical trials for this far-reaching revision of the regulatory framework the German Medical Association and the German Ethics Committees in summer 2020 published a curriculum for an update course (available in German only). You can find a discussion of this new curriculum in an article by Dr. Christoph Ortland (Forschungsdock GmbH) und Dr. Ingo Rath (CliPS - Clinical Project Services^®) published in the scientific journal PM/QM (follow this link for the article which is available in German only). 

At CliPS we are currently preparing to add this update course to our 2021 training portfolio in order to continue to offer the full spectrum of investigator trainings for clinical trials with medicinal products in Germany. In case of any questions regarding this new update course or investigator trainings in general, please do not hesitate to contact us.

The COVID-19 pandemic is a global crisis we cannot overcome with national measures alone. Unfortunately, it currently shows that we cannot solely rely on governments if it comes to confronting this pandemic in solidarity and thereby saving lives all over the world - including those areas where conditions to fight the virus are so much worse than in our own wealthy countries.

We at CliPS therefore support the WHO COVID-19 Solidarity Response Fund. Only together we are able to act in solidarity on a global scale. We thus kindly ask all visitors of our webiste to inform themselves about the WHO COVID-19 Soldarity Response Fund. The Fund relies on a global network in order to make donating as easy as possible. For Europe the Swiss Philanthropy Foundation is coordinating the collection of donations using the Transnational Giving Europe (TGE) network. Please visit the website of your local TGE partner organization in order to donate and to find out more about possible tax deductions.

Thank you and stay healthy!

Image Source: Public Health Image Library
CDC (Alissa Eckert, Dan Higgins)