• Regulatory NewsRegulatory News

    Health Canada Implements ICH Guideline on Good Clinical Practice

    Health Canada said Wednesday that it has implemented the International Council for Harmonisation’s (ICH) guideline on good clinical practice, known as E6(R2). While working to eliminate the differences between its own and ICH guidances, Health Canada said that in cases of such discrepancies, Health Canada-implemented ICH guidances should take precedence. The decision to implement the guideline in Canada follows the work of its ICH peer regulatory agencies to implemen...
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    ICH Offers Reflection Paper on Good Clinical Practice Revisions

    The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct. The scope of the revisions includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice , which is already undergoing modernization with the recent de...
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    ICH Advances Three Guidance Documents

    The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase. On the Step 4 front, the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced. “The current amendment (ICH E6(R...