• RF Quarterly

    RF Quarterly, June 22: Regulatory history

    Welcome to the June issue of RF Quarterly in which global regulatory experts write about Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), medical device regulations in China’s National Medical Products Administration (NMPA), and a personal reflection on 3 decades at the International Council for Harmonisation (ICH). Also included are articles on the development of clinical trial disclosure requirements, expedited pathways, and the De Novo pathway and the Final Ru...
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    ICH details milestones reached on guidelines after Athens meeting

    The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clinical trial data to the pediatric populations.   The ICH announcement follows its 21-25 May meeting in Athens, Greece which was held in a hybrid format. The meeting included seven working groups, as well as the ICH Management Committee...
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    Pharmaceutical industry groups suggest ICH Q9 changes

    The proposed revisions of the International Council of Harmonization’s (ICH) Q9 (R1) guideline on risk management should be better aligned with medical device quality risk standards as well as international standards. Further, a firm’s information technology (IT) program should be subject to the same level of risk controls as other areas within an organization, representatives of the pharmaceutical industry said in their comments on the update.   The European Medicin...
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    ICH drafts guideline on pediatric extrapolation in drug development

    The International Council for Harmonization (ICH) on Tuesday released a draft ICH E11A guideline that establishes a framework for extrapolating drug development data from adult trials to the pediatric population.   “This new ICH guideline aims to promote international harmonization of methodologies and strategies to incorporate paediatric extrapolation into overall drug development plans and to improve the speed of access to new drugs for paediatric patients, while l...
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    ICH releases draft guidelines on analytical method development

    The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for testing medicines postapproval and are aimed to promote more robust analytical processes.   The Q14 guideline would harmonize the scientific approaches for analytical procedures development while the Q2(R2) document covers the validation principles for the use of analytical procedures such as near-infrar...
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    ICH guide provides clarity on estimands, sensitivity analyses

    The International Council for Harmonization (ICH) has issued ICH E9 (R1) training materials meant to improve the planning, design, analysis and interpretation of clinical trials by defining suitable estimands.   The 238-page guide is meant to accompany an earlier addendum that presents a structured framework to link trial objectives to a suitable design; the addendum took effect in 30 July 2020 (RELATED:  ICH E9(R1) and S5(R3) to Take Effect in EU by End of July ...
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    ICH releases revised Q9 guideline to improve risk assessments

    The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of the revision is to provide “more scientific and robust applications of quality risk management principles (QRM)” leading to “fewer quality defects and recalls” and reduced costs for the pharmaceutical industry, according to an ICH business plan .   The ICH Q9(R1) guideline was published on the European Me...
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    Pharmaceutical groups want more clarity on continuous manufacturing guideline

    Several industry trade associations are asking for more clarity on the International Council for Harmonisation’s (ICH) Q13 guideline on continuous manufacturing, including what constitutes a state of control for a continuous manufacturing process, the scope of the guideline, and the definition of a batch size. One manufacturer said the guideline places too much emphasis on non-conforming material, which has not been a significant issue in continuous manufacturing.   Th...
  • RF Quarterly
    Feature ArticlesFeature Articles

    RF Quarterly, December 2021: Key takeaways from RAPS Convergence 2021

    Welcome to the December issue of RF Quarterly which focuses on key takeaways from RAPS Convergence 2021, including patient-focused approaches in regulatory decision making and drug development, the transition from convergence to harmonization for global pharmaceutical regulatory requirements, pediatric drug development, and regulatory and clinical strategies.   Patient perspective and global harmonization There is increasing recognition of the importance of patients...
  • RF Quarterly
    Feature ArticlesFeature Articles

    ICH implementation: The transition from convergence to harmonization

    This article examines the transition from convergence to harmonization for global pharmaceutical regulatory requirements. It outlines the roles of International Council for Harmonisation (ICH) and World Health Organization (WHO) in the implementation of ICH guidances and provides definitions for convergence and harmonization to reflect their distinctive roles. The authors also address ongoing harmonization initiatives, the current degree to which implementation has or has ...
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    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...