Название: ICH Quality Guidelines: An Implementation Guide
Автор: Teasdale A., Elder D., Nims R.
Издательство: Wiley
Год: 2018
ISBN: 978-1-118-97111-6
Формат: PDF
Страниц: 721
Размер: 3.9 Mb
Язык: English
The International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use was initiated in April 1990. ICH had the initial objective of coordinating the regulatory activities of the European, Japanese, and the United States bodies (along with the pharmaceutical trade associations from these three regions), to discuss and agree the scientific and technical aspects arising from product registration. This was recently supplemented by the addition of Health Canada and Swissmedic, to the core ICH Steering Committee (SC).
At the initial ICH SC meeting the terms of reference were agreed and it was decided that harmonisation initiatives would be divided into Safety (S), Quality (Q), and Efficacy (E), reflecting the main criteria which underpin the approval and authorization of new medicinal products. It was subsequently realised that several topics were multi?disciplinary (M) in nature