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
| Department/Agency |
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| Title | Therapeutic Products Directorate guidelines |
| Publication type | Series - Browse issue records |
| Language | [English] |
| Other language editions | [French] |
| Continued by | Guidance for industry |
| Format | Digital text |
| Other formats | Physical text-[English] |
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