📋 Tender Overview
Project No.
SCSC_06_2026S
Project Title
Improving the Planning, Design, and Review of Multi-Regional Clinical Trials (MRCT) for Pharmaceuticals through Capacity Building for Regulatory Authorities
Project Status
Project in Implementation
Fund Account
Self-Funded
Project Year
2026
Sponsoring Forum
Sub-Committee on Standards and Conformance (SCSC)
Topics
Conformance; Standards and Conformance
Committee
Committee on Trade and Investment (CTI)
Other Fora Involved
Other Non-APEC Stakeholders Involved
Proposing Economy(ies)
Japan
Co-Sponsoring Economies
United States
Expected Start Date
01/03/2026
Expected Completion Date
31/12/2026
Project Proponent Name 1
YASUDA Naoyuki
Job Title 1
Associate Executive Director
Organization 1
PMDA, Japan
Telephone 1
Not Applicable
Email 1
yasuda-naoyuki@pmda.go.jp
Project Proponent Name 2
Not Applicable
Job Title 2
Not Applicable
Organization 2
Not Applicable
Telephone 2
Not Applicable
Email 2
Not Applicable
Declaration
YASUDA Naoyuki
Project Cost (US$)
$0.00
Project Summary
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 Guideline establishes general principles for planning and designing multi-regional clinical trials (MRCTs) so that sponsors can generate evidence acceptable to multiple regulatory authorities, which enables more timely access to innovative medicines for patients in different regions. However, implementation of E17 across APEC economies is uneven, which can delay access to medicines and increase costs. This Project will convene experts from APEC regulatory authorities, industry, and academia to develop a curriculum and deliver a virtual workshop in July 2026 (TBC) to raise awareness of divergence in E17 implementation, deepen understanding of approaches to improve implementation, and strengthen communication between regulators and sponsors. The curriculum will then be integrated into future workshops through the RHSC.
