Description
The drug industry is one of the most heavily regulated in the world. The steady increase in globalization of the industry has motivated efforts to harmonize regulatory requirements – that is, to achieve some international standardization of the regulations. The principal vehicle for this effort is the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (the ICH).
Among the many guidance documents developed by the ICH, its guideline E6 on Good Clinical Practice is of major importance to all those involved in clinical research, whether they be drug company staff or healthcare professionals.
Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorization of clinical trials and the acceptance of their data in applications for marketing approval. The International Council for Harmonization’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.
In this module we describe the ICH’s role in the harmonization of regulations, introduce its guideline E6, and set out the principles of GCP.
