• Regulatory NewsRegulatory News

    EU official says ICH Q6B is outdated and needs revision

    The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concepts embodied in other ICH guidelines, according to a regulator from the EU.   Mats Welin, a senior expert for vaccines and monoclonal antibodies (MAbs) for the Swedish Medical Products Agency, made this assertion at the 30 November webi...
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    ICH recaps progress made over past year, charts new topics

    The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the release of question-and-answer guidelines related to the electronic Common Technical Document (eCTD).   Other accomplishments ICH cited in a recent summary of a mid-November virtual meeting include the advancement of a guideline on qu...
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    ICH Q12 guideline draws more comments from industry

    A major pharmaceutical industry group is calling for the US Food and Drug Administration (FDA) to institute several revisions to the International Council for Harmonization’s (ICH) Q12 guideline on postapproval changes.   The document was released by FDA for public feedback in May. (RELATED: ICH Q12: FDA guidance explains US implementation, Regulatory Focus , 21 May 2021).   The International Society for Pharmaceutical Engineering (ISPE) suggested in its 8 Oct...
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    FDA officials tout progress and achievements in advanced manufacturing

    The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in the agency’s Emerging Technologies Program (ETP).   In addition, “significant funding” from Congress has helped fund more research in advanced manufacturing, wrote Michael Kopcha, director of the Office of Pharmaceutical Quality in the FD...
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    ICH guideline proposes daily limits for seven mutagenic impurities

    The International Council for Harmonization (ICH) on Wednesday issued its M7(R2) guideline setting new permitted daily exposure (PDE) limits for seven DNA-reactive substances to limit their carcinogenic risk. The guideline is now available for public comment.   The guideline contains 21 mutagenic impurities, adding seven substances to the 14 previously published in the ICH M7(R1) guideline, which reached Step 4 in June 2017. (RELATED:   FDA Finalizes Guidance on Mut...
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    ICH announces sign-off on good clinical practices guideline

    The International Council for Harmonization (ICH) recently announced that the E8(R1) guideline on general considerations for clinical studies had reached Step 4 and is awaiting sign-off by regulators. The widely anticipated guideline modernizes the design, conduct and reporting of clinical trials by adopting quality by design principles. The guideline incorporates “current concepts achieving fit-for-purpose data quality.”   ICH announced that “the modernisation of IC...
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    China’s data localization‒centric policies and their impact on human research

    This article reviews Chinese laws governing healthcare data and genomic resources during 1998-2021 and their impact on clinical research in humans by pharmaceutical companies. Companies conducting such research must be vigilant about complying with the complex legal requirements governing the research and identifying potential risks and mitigation strategies for compliance. The analysis includes review of various legal requirements issued by the People’s Republic of China ...
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    ICH survey shows strong level of guideline implementation

    Most of the 55 guidelines from the International Council on Harmonisation that relate to quality, safety and efficacy, as well as multidisciplinary guidelines, have been adopted among its 10 non-founding members and observers and 30 pharmaceutical companies, according to the results of a new survey.   The survey was designed to monitor the adequacy and level of implementation to ICH guidelines by regulators and industry and complements one released in 2019 on the adopt...
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    FDA extends comment period on ICH Q12 guidance

    The US Food and Drug Administration (FDA) has reopened the comment period on its draft guidance implementing the International Council for Harmonization’s (ICH) Q12 guideline on postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.   The additional time was requested by the Pharmaceutical Research and Manufacturers of America (PhRMA).   FDA announced in a pre-publication notice in the 8 Septembe...
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    Industry wants clarity on established conditions, PACMPs, reporting categories in comments on ICH Q12

    Members of the pharmaceutical industry want the US Food and Drug Administration (FDA) to align reporting categories with the International Council for Harmonization (ICH) Q12 guideline on postapproval changes while others seek clarity on how manufacturers can use postapproval change management protocols (PACMPs) to support a lower reporting category. Others wanted clarity on established conditions (ECs) as well as non-ECs, a core tenet of the guideline.   These industr...
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    ICH releases widely anticipated guidance on continuous manufacturing

    The International Council for Harmonisation (ICH) on Tuesday issued its Q13 guideline on continuous manufacturing, making a draft available for public comment.   The long-awaited draft was soon expected, according to an FDA official who gave an update on the status of the guideline at a 14 July CMC Strategy Forum sponsored by the California Separation Science Society (CASSS). (RELATED: Long-awaited ICH continuous manufacturing guideline coming soon , Regulatory Foc...
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    Long-awaited ICH continuous manufacturing guideline coming soon

    The International Council for Harmonization (ICH) Q13 guideline on continuous manufacturing is expected to be released for public comment soon, as the US pharmaceutical industry continues slow but steady adoption of this mode of manufacturing.   Cyrus Agarabi, a reviewer in FDA’s Office of Biotechnology Products in the Office of Pharmaceutical Quality, updated attendees on the status of the ICH Q13 guideline at the 14 July CMC Strategy Forum sponsored by the California...