What ICH E8(R1) - General Considerations for Clinical Studies 2021: Quality, Risk-Based Approaches and Fit-for-Purpose Clinical Study Design requires
This regulation requires that clinical studies be designed to ensure the quality, safety, and efficacy of investigational products, as outlined in Article 1 of the ICH E8(R1) guideline, and applies to all clinical studies conducted to support regulatory submissions.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 1.0.1 · Last updated:
Primary source: https://www.ich.org/page/efficacy-guidelines
SHA-256 integrity: 1667a4f8235782a426a9f2832a1d96b6079cd2e7df3757399da6b3cfea2afd7b
Primary Citations — 9 traced to source
- ICH E8(R1), Article 1 - General Considerations for Clinical Studies
- ICH E8(R1), Article 2 - Risk-Based Approaches
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