00000nas 2200000za 4500 9.506920 CaOODSP 20200331213158 cr ||||||||||| 150406d19971997xxc|| m o||||f| |0eng|d CaOODSP eng n-cn--- H42-2/2E-PDF Canada. Health Canada. Therapeutic Products Directorate. Therapeutic Products Directorate guidelines [electronic resource] Ottawa - Ontario : Health Canada. "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. Drugs gcpds Directives de la Direction des produits thérapeutiques (CaOODSP)9.503316 Therapeutic Products Directorate guidelines (CaOODSP)9.514729 Guidance for industry (CaOODSP)9.506921