On 26 May 2023, the European Medicines Agency (EMA) published the draft ICH E6 (R3) guideline on good clinical practice (GCP) – step 2b and the template for comments to the ICH E6 (R3) guideline on good clinical practice.
The document has been submitted for public consultation and the comments will be collected until September 26, 2023. Stakeholders from ICH member countries/regions may submit comments to the relevant regulatory authorities, noting the comment deadline indicated under the draft Guidance.
The changes in the ICH E6 (R3) Guideline on good clinical practice (GCP) compared to ICH E6 (R2) cover several important aspects.
The concerned changes include:
- introduction of a risk-based approach – this change requires sponsors of clinical trials to focus on the most important aspects of ensuring the quality and integrity of clinical data, rather than focusing on every aspect of clinical trials equally,
- the need to integrate a patient perspective into all aspects of clinical trials, including study design and patient safety decision-making,
- the use of modern technologies, including e-visits, remote patient monitoring and telemedicine, to increase the efficiency and effectiveness of clinical trials,
- more detailed documentation of the decision-making process and all actions taken by researchers and research sponsors,
- a stronger focus on transparency and accessibility of information for patients and the public,
- incorporating sustainability principles – this change requires researchers and sponsors of clinical trials to integrate sustainability principles into the design and conduct of clinical trials,
- the requirement to apply new standards in the field of quality management systems.
These changes are aimed to improve the quality and integrity of clinical data, protection of the right of the participating patients, as well as increasing patient and public confidence in research as a tool to improve health and quality of life – as well as increasing the protection of the rights and safety of patients participating in clinical trials. Of course, patients’ safety remains a paramount issue.
Our domain at SciencePharma is our excellent knowledge of current guidelines. We always stay up to date with the upcoming changes and actively participate in their consultations. If you want to rely on a reliable partner with up-to-date knowledge, we recommend our services.