Therapeutic Products Directorate guidelines : H42-2/2E-PDF

"The ICH harmonised tripartite guideline: "General Considerations for Clinical Trials" has been developed by an ICH Expert Working Group and has been subject to consultation, in accordance with the ICH process, by regulatory parties which include Canada. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan, and the USA. [...] The Therapeutic Products Directorate of Health Canada has adopted this international guideline in order to provide a comprehensive document that relates the clinical phases of drug development to specific topic-related harmonized guidelines."--Foreword.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.506920&sl=0

Publication information
Department/Agency Canada. Health Canada. Therapeutic Products Directorate.
Title Therapeutic Products Directorate guidelines
Publication type Series - Browse issue records
Language [English]
Other language editions [French]
Continued by Guidance for industry
Format Electronic
Other formats Paper-[English]
Publishing information Ottawa - Ontario : Health Canada.
Catalogue number
  • H42-2/2E-PDF
Subject terms Drugs
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