Symposium for the Draft ICH E8 (R1) - MHLW/PMDA International Activities

Aug 26, 2026

Briefing on MHLW/PMDA international activities delivered at the symposium for the draft ICH E8 (R1), covering multilateral cooperation to advance regulatory harmonization and convergence across Asia/Pacific. 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.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages30

Reading Time1 h 16 min

AccessFree to download

Outline

Multilateral Cooperation to Foster Regulatory Harmonization/Convergence

Initiatives toward Regulatory Harmonization/Convergence in Asia/Pacific Region

Next Step

ICMRA Innovation Project

Work Stream 1-3

Future ICMRA Activities

International Council for Harmonization of Technical Requirements (ICH)

MedDRA

Symposium for the draft ICH E8 (R1) 25 July, 2019, Yomiuri Holl, Tokyo, Japan MHLW/PMDA international activities Nobumasa NAKASHIMA, Ph.D. Senior Director for International Programs Pharmaceuticals and Medical Devices Agency (PMDA) Outline 1. Multilateral Cooperation to Foster Regulatory Harmonization/Convergence 2 . Initiatives toward Regulatory Harmonization/Convergence in Asia/Pacific Region 3. Next Step The International Coalition of Medicines Regulatory Authorities (ICMRA) 􀂾 ICMRA provides a global architecture to support enhanced communication, information sharing, crisis responses and address regulatory science issues. 􀂾 MHLW/PMDA lead ICMRA Innovation Work Stream 1 To 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. Leader AIFA, DKMA, EMA, US.FDA, HC, HPRA, MFDS, MHRA, MPA, Swissmedic 4 What is Horizon Scanning?~ Illustration of Horizon Scanning ~ 1. Identification | Identify pool of novel technologies
| | | | --- | --- | --- | 4. Dissemination/ Regulatory Action Assessments presented to management | | | Etc | | --- | --- | --- | | | Hire Experts on Technology | | ICMRA Innovation Project led by MHLW/PMDA Analysis of global best practices in horizon scanning methodologies Work Stream 1: • Survey of members to analyse existing HS methodologies and approaches • Identification of HS best practices and development of a HS methodology framework | Work Stream 2: | Leveraging from outcomes of horizon scanning
through critical innovation/ expertise and skills | led by EMA, HPRA | | --- | --- | --- | • Compilation of three case studies to identify and review products and technologies, where regulatory science approaches are required. • Discussions regarding future expertise requirements and potential opportunities for collaboration and capacity building to support innovation | | Novel Approaches to Licensing/ Early Access Schemes | | --- | --- | led by Health Canada Work Stream 3: • Review of various international regulatory approaches to licensing that aim to address the demand for timely access to innovative products. • Questionnaire among ICMRA members regarding current novel regulatory pathways to licencing (NRPL) and which are implemented through legislation, regulation, and policy. Future ICMRA Activities • On June 23, PMDA’s Chief Executive, Dr. Yasuhiro Fujiwara, was elected as ICMRA’s New Vice Chair 2019 in ICMRA meeting held in San Diego. • 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. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) 􀂾 ICH is unique in bring together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. 􀂾 ICH aims to achieve harmonization through the development of ICH Guidelines with regulator and industry experts. 􀂾 ICH has produced over 60 Guidelines on technical requirement. 􀂾 Over 20 working groups are now ongoing. ICH was created in 1990 and 30 th Anniversary in 2020. 9 Others, 20 MedDRA Med = Medical D = Dictionary for 􀂾 MedDRA – International standard for electronic safety data exchange, used through the entire regulatory process, from pre-marketing to post-marketing, and R = Regulatory A = Activities data entry, retrieval, evaluation and presentation. 􀂾 2019 marks 20 years of MedDRA which was first released in 1999 . 􀂾 12 languages, Over 5,700 MedDRA Subscribing Organizations in 122 Countries Countries with MedDRA Subscribing Organizations 10

FAQs

What is the purpose of the symposium for the draft ICH E8 (R1)?

The symposium briefing focuses on regulatory harmonization efforts and international activities relevant to ICH E8 (R1), including ICMRA initiatives and horizon scanning.

How does ICMRA support regulators and regulatory science issues?

ICMRA provides a global architecture for enhanced communication, information sharing, crisis responses, and addressing regulatory science issues.

What does the document describe under horizon scanning?

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.

Which areas do ICMRA Innovation Project work streams cover?

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.

Aug 26, 2026

Uploaded by Emma Wilson