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Explains the ICMRA role in enabling communication, information sharing, crisis response, and regulatory-science issue management, with a focus on horizon scanning best practices. Details ICMRA innovation work streams, member surveys, case studies, licensing and early access schemes, and future capacity-building collaboration. Includes context on ICH and MedDRA international standards.",{"@graph":69,"@context":126},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/symposium-for-the-draft-ich-e8-r1-mhlwpmda-international-activities/148941/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/symposium-for-the-draft-ich-e8-r1-mhlwpmda-international-activities/148941.png","ImageObject",300,407,{"name":92,"@type":93},"Emma Wilson","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-17","2026-08-26",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118,122],{"name":109,"@type":110,"acceptedAnswer":111},"What is the purpose of the symposium for the draft ICH E8 (R1)?","Question",{"text":112,"@type":113},"The symposium briefing focuses on regulatory harmonization efforts and international activities relevant to ICH E8 (R1), including ICMRA initiatives and horizon scanning.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How does ICMRA support regulators and regulatory science issues?",{"text":117,"@type":113},"ICMRA provides a global architecture for enhanced communication, information sharing, crisis responses, and addressing regulatory science issues.",{"name":119,"@type":110,"acceptedAnswer":120},"What does the document describe under horizon scanning?",{"text":121,"@type":113},"It outlines horizon scanning with an identification step to identify a pool of novel technologies, followed by dissemination and regulatory-action assessments presented to management.",{"name":123,"@type":110,"acceptedAnswer":124},"Which areas do ICMRA Innovation Project work streams cover?",{"text":125,"@type":113},"Work Stream 1 surveys members to analyze horizon scanning methodologies and builds a framework; Work Stream 2 leverages outcomes for expertise and skills; Work Stream 3 reviews international licensing approaches for timely access and collects member input on novel regulatory pathways.","https://schema.org",{"og:url":83,"og:type":128,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":130,"canonical":83},"index,follow",{"doc_id":132,"site_id":62},148941,1787788143,{"code":4,"msg":5,"data":135},{"doc_id":132,"user_id":136,"nickname":92,"user_avatar":137,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":138,"file_id":139,"file_url":140,"file_type":141,"file_size":142,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":41,"language":143,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":144,"faqs":145,"seo_title":146,"seo_description":67,"update_tm":133,"read_time":147,"preview_page_count":4},3848291630094,"https://eur-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","Symposium for the draft ICH E8 (R1)  \n25 July, 2019, Yomiuri Holl, Tokyo, Japan  \nMHLW/PMDA international activities  \nNobumasa NAKASHIMA, Ph.D.  \nSenior Director for International Programs Pharmaceuticals and Medical Devices Agency (PMDA)  \nOutline  \n1. Multilateral Cooperation to Foster Regulatory Harmonization/Convergence  \n2 . Initiatives toward Regulatory  \nHarmonization/Convergence in Asia/Pacific Region  \n3. Next Step  \nThe International Coalition of Medicines Regulatory  \nAuthorities (ICMRA)  \n􀂾 ICMRA provides a global architecture to support enhanced communication, information sharing, crisis responses and address regulatory science issues.  \n􀂾 MHLW/PMDA lead ICMRA Innovation Work Stream 1  \n\u003CMission>  \nTo identify best practices of horizon scanning (HS) through compiling and analyzing each regulator’s scanning methods and to find solutions to common difficulties faced by the regulators.  \n\u003CMembers>  \nLeader  \nAIFA, DKMA, EMA, US.FDA, HC, HPRA, MFDS, MHRA, MPA, Swissmedic  \n4  \nWhat is Horizon Scanning?~ Illustration of Horizon Scanning ~  \n1. Identification  \n| Identify pool of novel technologies  \u003Cbr>| | |\n| --- | --- | --- |\n\n4. Dissemination/  \nRegulatory Action Assessments presented to management  \n| | | Etc   |\n| --- | --- | --- |\n|  | Hire Experts on Technology  |  |\n\nICMRA Innovation Project  \nled by MHLW/PMDA  \nAnalysis of global best practices in horizon scanning methodologies  \nWork Stream 1:  \n• Survey of members to analyse existing HS methodologies and approaches  \n• Identification of HS best practices and development of a HS methodology framework  \n\n| Work Stream 2: | Leveraging from outcomes of horizon scanning\u003Cbr>through critical innovation/ expertise and skills | led by EMA, HPRA |\n| --- | --- | --- |\n\n• Compilation of three case studies to identify and review products and technologies, where regulatory science approaches are required.  \n• Discussions regarding future expertise requirements and potential opportunities for collaboration and capacity building to support innovation  \n\n|  | Novel Approaches to Licensing/ Early Access Schemes |\n| --- | --- |\n\nled by Health Canada  \nWork Stream 3:  \n• Review of various international regulatory approaches to licensing that aim to address the demand for timely access to innovative products.  \n• Questionnaire among ICMRA members regarding current novel regulatory pathways to licencing (NRPL) and which are implemented through legislation, regulation, and policy.  \nFuture ICMRA Activities  \n• On June 23, PMDA’s Chief Executive, Dr. Yasuhiro Fujiwara, was elected as ICMRA’s New Vice Chair  \n2019 in ICMRA meeting held in San Diego.  \n• Dr. Fujiwara will lead ICMRA along with Prof. Guido Raji, Executive Director of European Medicines Agency, elected as new Chair, and Prof. John Skerritt, Deputy Secretary for Health Products Regulation Department of Health, Australia, elected another Vice Chair.  \nInternational Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)  \n􀂾 ICH is unique in bring together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.  \n􀂾 ICH aims to achieve harmonization through the development of ICH Guidelines with regulator and industry experts.  \n􀂾 ICH has produced over 60 Guidelines on technical requirement.  \n􀂾 Over 20 working groups are now ongoing.  \nICH was created in 1990 and 30 th Anniversary in 2020.  \n\u003CNumber of experts in ICH>  \n9  \nOthers, 20  \nMedDRA  \nMed = Medical  \nD = Dictionary for  \n􀂾 MedDRA – International standard for electronic safety data exchange, used through the entire regulatory process, from pre-marketing to post-marketing, and  \nR = Regulatory A = Activities  \ndata entry, retrieval, evaluation and presentation.  \n􀂾 2019 marks 20 years of MedDRA which was first released in 1999 .  \n􀂾 12 languages, Over 5,700  \nMedDRA Subscribing Organizations in 122 Countries  \nCountries with MedDRA Subscribing Organizations  \n10","cbCaifsURv7onpvc","https://ap.wps.com/l/cbCaifsURv7onpvc","pdf",3228818,"English","# Outline\n## Multilateral Cooperation to Foster Regulatory Harmonization/Convergence\n## Initiatives toward Regulatory Harmonization/Convergence in Asia/Pacific Region\n## Next Step\n## ICMRA Innovation Project\n## Work Stream 1-3\n## Future ICMRA Activities\n## International Council for Harmonization of Technical Requirements (ICH)\n## MedDRA","[{\"question\":\"What is the purpose of the symposium for the draft ICH E8 (R1)?\",\"answer\":\"The symposium briefing focuses on regulatory harmonization efforts and international activities relevant to ICH E8 (R1), including ICMRA initiatives and horizon scanning.\"},{\"question\":\"How does ICMRA support regulators and regulatory science issues?\",\"answer\":\"ICMRA provides a global architecture for enhanced communication, information sharing, crisis responses, and addressing regulatory science issues.\"},{\"question\":\"What does the document describe under horizon scanning?\",\"answer\":\"It outlines horizon scanning with an identification step to identify a pool of novel technologies, followed by dissemination and regulatory-action assessments presented to management.\"},{\"question\":\"Which areas do ICMRA Innovation Project work streams cover?\",\"answer\":\"Work Stream 1 surveys members to analyze horizon scanning methodologies and builds a framework; Work Stream 2 leverages outcomes for expertise and skills; Work Stream 3 reviews international licensing approaches for timely access and collects member input on novel regulatory pathways.\"}]","Symposium for the Draft ICH E8 (R1) - MHLW/PMDA International Activities | PDF",76]