Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 65

The good clinical practice guidelines, which are the blueprint for this entire text, are a work product of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH, which was initiated circa 1990 by the US FDA, EC/EMA and Japan’s MHLW along with corresponding pharmaceutical industry associations sought to pursue the harmonization of requirements leading to drug registration or approval. Their harmonization effort has led to the removal of unnecessary and often redundant requirements. The ICH has now evolved from a joint commitment of three government organizational units and three industry associations to a legal nonprofit international association under Swiss law. Understanding the ICH organization, its mission and roles is useful. However we suggest you visit the ICH Webpage [1] for insight into all of its history and accomplishments. The webpage is quite complete, easy to navigate, and transparent.

Since governmental requirements are the underlying foundation of ICH E6(R2) the there is merit in outlining some key points about the regulatory processes, leading to a successful drug registration or approval. The drug development process calls on a wide range of disciplines and while each may not appear to be a direct player in meeting GCP expectations they are all connected.

A key player or set of players in the drug development process will be from the sponsor’s regulatory affairs group. Understanding their roles and responsibilities as they relate to clinical development is useful.