International Council For Harmonisation (ICH)

Context:
- It can define Clinical Trial Institutional Review Board (IRB)s.
- It can define ICH Guidelines.
- …
See: ICH ALCOA+, ICH for Good Clinical Practice (GCP), Pharmaceutical Product Registration, ICG GCP E6 R2, Good Documentation Practice.

References

(Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use Retrieved:2021-10-25.
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.
  The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements."

(Vijayananthan & Nawawi, 2008) ⇒ Anushya Vijayananthan, and O. Nawawi. (2008). “The Importance of Good Clinical Practice Guidelines and Its Role in Clinical Trials.” Biomedical imaging and intervention journal 4, no. 1
- ABSTRACT: Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.