Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: Q9: Quality Risk Management

Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: Q9: Quality Risk Management Q9: Quality Risk Management. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA. 2023-11-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyinternational-conference on harmonisationICHICH of technical-requirementsregistration of pharmaceuticalspharmaceuticals for human-useICH guidanceQ9quality risk management Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: Q9: Quality Risk ManagementHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/adoption-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use.html Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: Q9: Quality Risk ManagementHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/qualite/adoption-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-2.html

Q9: Quality Risk Management. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

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