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    To speed drug development, ICH proposes reducing rat carcinogenicity testing

    The International Council for Harmonisation (ICH) recently announced a new draft guideline that proposes a “weight of evidence” approach to inform whether a two-year rat study would add value in evaluating a drug’s carcinogenic risks.   The proposed guideline provides more detailed guidance for drug developers who are considering whether rodent studies are needed to assess carcinogenicity. The ICH S1B(R1) addendum, once adopted, should be used in conjunction with the I...
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    FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers

    The US Food and Drug Administration (FDA) on 11 May made available an International Council for Harmonisation’s (ICH) guideline on postapproval changes for drug products and issued four other final ICH documents and one draft guidance.   The ICH Q12 guideline aims to facilitate the management of postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances and is the same as the version endorsed by ICH as a ...
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    ICH announces sign-off of residual solvent guideline

    The International Council for Harmonization (ICH) recently announced that its guideline establishing new permitted daily exposures (PDEs) for three residual solvents had reached Step 4, meaning the guideline can now be implemented by regulators.   The ICH Q3C(R8) guideline has been revised to include permitted daily exposure (PDE) levels for 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME) and tertiary butyl alcohol (TBA). The PDE for 2-methyletrahydro...
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    ICH announces new data exchange with SNOMED to promote drug safety

    The International Council for Harmonization (ICH) announced on 29 April the release of its first set of data maps with SNOMED International that facilitates the exchange of adverse event reports and other important epidemiologic information between regulators and researchers.   This release of the maps is the first deliverable of an agreement between SNOMED International and ICH that aims to promote drug safety. The ICH Medical Dictionary for Regulatory Activities (...
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    ICH shares "work-in-progress" update to GCP guidance

    The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.   “The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliabl...
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    ICH updates focus on patient-focused drug development, nitrosamines

    The International Council for Harmonisation (ICH) has shared an update on its initiatives, revealing recent progress in areas including its position on elemental impurities and the role patients can play in drug development.   ICH met virtually last month in lieu of a face-to-face gathering that was to take place in Greece. At the event, ICH’s second virtual gathering of 2020, the management committee re-elected FDA’s Theresa Mullin for another one-year term as manag...
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    Drug mutagenicity, proarrhythmic potential addressed in pair of FDA guidances

    The US Food and Drug Administration (FDA) has issued two new draft International Council on Harmonisation (ICH) guidelines for public consultation.   A question-and-answer (Q&A) guidance on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of medicines was published in draft form by FDA on 29 September; the guidance is currently in ICH Step 2b, awaiting consultation from the Council's participating countries. The draft guid...
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    ICH updates: E14 consultation, Health Canada implements M9 guideline

    The International Council for Harmonisation (ICH) on Thursday announced its E14/S7B draft questions and answers guideline on clinical and nonclinical evaluation of QT/QTc interval and proarrhythmic potential has reached Step 2b of the ICH process.   On Friday, the European Medicines Agency (EMA) opened a three-month public consultation to gather feedback on the document. ICH will also be hosting a two-day public meeting to provide a high-level overview of the docum...
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    ICH Reverts to Previous Version of Guideline on Residual Solvents

    The International Council for Harmonisation (ICH) has further explained why it decided to go back and change the Permissible Daily Exposure (PDE) for ethylene glycol (EG), and then more recently, to reverse that decision and revert back to the original figure. Prior to 2017, the ICH Q3C guideline, which deals with residual solvents, included a Summary Table 2 that listed EG as a Class 2 residual solvent with a PDE of 6.2 mg/day. But in 2017, ICH was notified by an exter...
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    ICH Adds Four New Regulatory Observers

    Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals came at a meeting from 1-6 June in Amsterdam. ICH said the meeting was its largest biannual meeting ever and that progress was made on existing guidelines, training materials to support guideline implementation, the details of an ICH meeting in Silver Spring, MD, on 31 October on the revisi...
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    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 Advances Revised Guideline on Elemental Impurities

    The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for Elemental Impurities, developed via the International Council for Harmonisation (ICH), reached the fourth out of five steps in ICH’s process of regulatory harmonization last week, moving toward implementation of the revised guideline. The guideline was first recommended for...