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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Euro Convergence: Academic clinics should establish risk management programs for ATMP development

    Academic centers should establish risk management programs to successfully commercialize cell and gene therapy products and to be a viable partner with contract research organizations (CROs) and manufacturers in developing these therapies.   So asserted Lutz Uharek, a professor of internal medicine and founder and CEO of Xencura, at RAPS Euro Convergence 2021 on 12 May in discussing some of the challenges and opportunities for academic centers in developing cell and ge...
  • FDA Adopts ICH Guidance on Pharmaceutical Quality

    The US Food and Drug Administration (FDA) released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan. The guidance is co-sponsored by FDA's Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), both of which are in charge ...