Consultations - International Council for Harmonisation
- Consultation: Release of Draft ICH : Q9(R1): Quality Risk Management [2022-01-14]
- Consultation: Release of Draft (Step 2) ICH Guideline: M7(R2): Addendum to the Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2021-11-12]
- Consultation: Release of Draft (Step 2) ICH Guidance: Q13: Continuous Manufacturing of Drug Substances and Drug Products [2021-10-28]
- Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [2021-08-26]
- Consultation: Release of Draft (Step 2) ICH Guidance: S12: Nonclinical Biodistribution Considerations for Gene Therapy Products [2021-07-05]
- Consultation: Release of Draft (Step 2) ICH Guidance: S1B(R1): Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals [2021-06-10]
- Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [2021-04-16]
- Consultation: ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient-Focused Drug Development [2020-12-16]
- Release of Draft (Step 2) ICH Guidance: Q3D(R2): Impurities: Elemental Impurities [2020-09-29]
- Consultation: Release of Draft (Step 2) ICH Guidance: E14/S7B: Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential [2020-09-21]
- Release of draft (step 2) ICH guidance: M7(R2): Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2020-07-07]
- Release of draft (Step 2) ICH guidance: Q3C(R8): Impurities: Residual solvents [2020-06-30]
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