No, the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines are not applicable to non-interventional studies (NIS) in the context of real-world evidence (RWE).

ICH GCP guidelines are designed to ensure the protection of human subjects and the quality and integrity of data generated in clinical trials of investigational medicinal products (IMPs). In contrast, NIS are observational studies that do not involve the administration of IMPs, and instead rely on the collection of data from routine clinical practice or other non-experimental settings.

However, there are other guidelines and frameworks that apply to non-interventional studies in the context of real-world evidence, such as the International Society for Pharmacoepidemiology’s (ISPE) “Guidelines for Good Pharmacoepidemiology Practices” (GPP).

It is important to note that while NIS may not be subject to the same regulatory requirements as clinical trials, they still need to adhere to the applicable local regulations, ethical and scientific standards, and to ensure the protection of patient privacy and confidentiality.