ICH Assembly Decisions and Progress Report on Medicines for Children and Clinical Trials
International Council for Harmonisation Assembly
The International Council for Harmonisation (ICH) Assembly met in Montreal, Canada, making significant decisions and progress in the field of medicines for children and clinical trials. The Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, expanding the collaboration to improve healthcare standards. Additionally, the Assembly agreed to work on developing a new international harmonized guideline on extrapolation for pediatric medicines. This initiative aims to enhance the utilization of pediatric extrapolation to expedite access to new drugs for children, a crucial step in improving pediatric healthcare.
Furthermore, the ICH Assembly decided to revise the 1997 ICH E8 guideline on general considerations for clinical trials, as part of the strategic ‘GCP renovation’ announced in Osaka in November 2016. This revision will focus on enhancing study design, planning, and conduct by identifying critical factors for quality. By improving clinical trials, the aim is to provide better evidence for regulatory decision-making, reduce the need for repeat trials, and enhance participant safety, ultimately contributing to the advancement of public health.
The Assembly also finalized important guidelines, including the M7(R1) addendum on the Assessment and Control of DNA Reactive Impurities in Pharmaceuticals and the update of Questions and Answers on the guideline E2B(R3) for Electronic Transmission of Individual Case Safety Reports. In an effort to streamline operations and accommodate a growing number of members and observers, the Assembly made revisions to the Articles of Association and rules of procedure. The goal is to ensure that Expert Working Groups remain manageable in size and to engage with relevant global organizations effectively, showcasing ICH’s commitment to agile growth and harmonization. The ICH Assembly’s efforts demonstrate a proactive approach to improving healthcare standards and advancing regulatory practices in the pharmaceutical industry.
