FROM REGIONAL PRINCIPLES TO LOCAL IMPLEMENTATION: HOW CHINA’S NHSA AND JAPAN’S C2H GUIDELINES BUILD ON THE ASIA-PACIFIC REALISE GUIDANCE FOR REAL-WORLD EVIDENCE USE IN HTA
Author(s)
Yan Ran Wee, BSocSci, MSc, Chen Yin, MD, Natsumi Fujita, BSc, Andrew Lim, BSc, Jennifer Sara Evans, BSc, PhD.
Costello Medical Singapore Pte Ltd, Singapore, Singapore.
Costello Medical Singapore Pte Ltd, Singapore, Singapore.
OBJECTIVES: To review guidance from health technology assessment (HTA) bodies in Japan and China regarding the use of real-world evidence (RWE) for healthcare reimbursement decision-making.
METHODS: Guidelines on RWE use released in 2026 by China’s National Healthcare Security Administration (NHSA) and submission guidance from Japan’s Center for Outcomes Research and Economic Evaluation for Health (C2H) from 2024-2025 were reviewed and mapped against the regional REAL World Data (RWD) In ASia for HEalth Technology Assessment (REALISE) guidance. Sections from local guidance were categorised as “agree”, “mixed”, “disagree” or “missing” based on coverage and alignment.
RESULTS: China’s NHSA had six RWE-specific guidelines, whereas C2H minimally referred to RWE within its reimbursement dossier guidance. Across NHSA guidelines, 64% of sections mapped to REALISE (23% “agree”, 41% “mixed”). There was strong alignment on high-level RWE principles, e.g. research transparency and rigour; differences in “mixed” sections related to translation of these standards into specific local requirements (e.g. protocol pre-registration with NHSA, inclusion of NHSA-approved trusted sites in multicentre studies). Sections tagged as “missing” (36%) detailed local policies (e.g. price negotiation incentives for generating high-quality RWE) or processes unique to China’s HTA context (e.g. peer-review, audit). Japan’s C2H did not have specific guidelines regarding RWE; its dossier guidance had no disagreements with overarching RWE principles outlined in REALISE (33% “agree”), but 66% of relevant sections were tagged “mixed” due to lack of detail and their focus on the limitations of RWE, with limited discussion of its strengths or appropriate applications.
CONCLUSIONS: Regional and local guidelines were broadly aligned regarding the need for high-quality RWE for HTA. Detailed guidance provided by China’s NHSA signals support for the growing role of high-quality RWE in HTA, whereas the lack of specific guidance from Japan’s C2H, despite its relatively mature RWE landscape, suggests a currently more conservative role for RWE in Japanese HTA.
METHODS: Guidelines on RWE use released in 2026 by China’s National Healthcare Security Administration (NHSA) and submission guidance from Japan’s Center for Outcomes Research and Economic Evaluation for Health (C2H) from 2024-2025 were reviewed and mapped against the regional REAL World Data (RWD) In ASia for HEalth Technology Assessment (REALISE) guidance. Sections from local guidance were categorised as “agree”, “mixed”, “disagree” or “missing” based on coverage and alignment.
RESULTS: China’s NHSA had six RWE-specific guidelines, whereas C2H minimally referred to RWE within its reimbursement dossier guidance. Across NHSA guidelines, 64% of sections mapped to REALISE (23% “agree”, 41% “mixed”). There was strong alignment on high-level RWE principles, e.g. research transparency and rigour; differences in “mixed” sections related to translation of these standards into specific local requirements (e.g. protocol pre-registration with NHSA, inclusion of NHSA-approved trusted sites in multicentre studies). Sections tagged as “missing” (36%) detailed local policies (e.g. price negotiation incentives for generating high-quality RWE) or processes unique to China’s HTA context (e.g. peer-review, audit). Japan’s C2H did not have specific guidelines regarding RWE; its dossier guidance had no disagreements with overarching RWE principles outlined in REALISE (33% “agree”), but 66% of relevant sections were tagged “mixed” due to lack of detail and their focus on the limitations of RWE, with limited discussion of its strengths or appropriate applications.
CONCLUSIONS: Regional and local guidelines were broadly aligned regarding the need for high-quality RWE for HTA. Detailed guidance provided by China’s NHSA signals support for the growing role of high-quality RWE in HTA, whereas the lack of specific guidance from Japan’s C2H, despite its relatively mature RWE landscape, suggests a currently more conservative role for RWE in Japanese HTA.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
RWD16
Topic
Real World Data & Information Systems
Topic Subcategory
Data Protection, Integrity, & Quality Assurance
Disease
No Additional Disease & Conditions/Specialized Treatment Areas