Technical Requirements for Registration of Pharmaceuticals for Human Use: The ICH Process

This chapter sets out the International Conference on Harmonisation organization, the process and the development of guidelines with regards to quality, safety, efficacy and regulatory obligations for global development of new medicines, and including the adoption of a Common Technical Document.

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Bibliographic Details
Published inThe Textbook of Pharmaceutical Medicine pp. 447 - 460
Main Author Harron, Dean W. G
Format Book Chapter
LanguageEnglish
Published Oxford, UK Blackwell Publishing Ltd 18.04.2013
Subjects
Common Technical Document
efficacy
ICH process
new medicines
quality
regulatory processes
safety
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Summary:This chapter sets out the International Conference on Harmonisation organization, the process and the development of guidelines with regards to quality, safety, efficacy and regulatory obligations for global development of new medicines, and including the adoption of a Common Technical Document.
ISBN:9780470659878
0470659874
DOI:10.1002/9781118532331.ch23