Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 49

GCP Key Point

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GCP expectation intersects the entire functional scheme of clinical development for pharmaceutical medicinal products. Understanding the intersections is useful and enlightening.

The emergence of the ICH closely parallels with the emergence of current GCP because the ICH served as a catalyst for development of Standards such as the ICH E6(R2). The ICH‐GCP (R1) was one of the first standards developed by the ICH. It was recognized that such a standard was needed. Regulatory Authorities had worked on building the GCP expectations into their regulatory schemes by detailing them in codes or regulations then interpreting the codes using mechanisms such as inspections and industry meeting presentations. The World Health Organization (WHO) had pursued developing principles of good clinical research practice as early as the late 1960s however the WHO was not a regulatory or standard setting organization so their guidance did not represent requirements nor was it mandated under any laws. The regulatory authorities were not working collaboratively to further their GCP thinking and as a result the requirements across countries and regions were evolving differently. It took an industry‐regulatory authority initiative – The ICH – to open the door to establishing a pathway for harmonization of GCP as well as other drug development requirements. That initiative has flourished and expanded.

The Fundamentals of Clinical Research

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