E23 – Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines

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E23 – Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines

This topic was endorsed by the ICH Assembly in May 2025, and the E23 Working Group has been established to develop a final Concept Paper.

Endorsed Documents

E23 Concept Paper

E23 Work Plan

Ongoing public consultations

No results found.

E23 Expert Working Group

Rapporteur

Dr. Patrice VerpillatEC, Europe

Regulatory Chair

Mr. Andrew RavenHealth Canada, Canada

Experts

ANMAT, ArgentinaDr. Fanny Ruth Kataife

ANVISA, BrazilMs. Brenda Gomes Valente

BIODr. Rachel Sobel

CECMED, CubaMs. Carlos Sánchez Texido

CIOMSDr. Yoshiko Atsuta

DINAVISA, ParaguayMr. Oscar Allende

EC, EuropeDr. Florian Lasch

EC, EuropeDr. Carla Torre

EDA, EgyptDr. Heba Ali

EFPIADr. Gracy Crane

EFPIADr. Lotte Husemoen

FDA, United StatesDr. Jennifer Kirk

FDA, United StatesDr. Motiur Rahman

Global Self-Care FederationDr. Andrew Stewart

IFPMAMs. Min Zhu

IGBADr. Sigal Kaplan

JFDA, JordanDr. Jaber Jaber

JPMAMr. Satoshi Yoshida

JPMADr. Seitaro Yoshida

MFDS, Republic of KoreaDr. Hyun Ok Seo

MHLW/PMDA, JapanMr. Ryota Kimura

MHLW/PMDA, JapanMs. Hiromi Takizawa

MHRA, UKDr. Rebecca Ghosh

MOH, KuwaitDr. Reem Al Essa

NMPA, ChinaDr. Jun Wang

PhRMADr. Kourtney Davis

PhRMADr. Andres Gomez-Caminero

PPBHK, Hong Kong, ChinaMr. Ka Cheong Chung

Roszdravnadzor, RussiaDr. Renad Alyautdin

SAHPRA, South AfricaMs. Margaret Malatji

SFDA, Saudi ArabiaMr. Ahmed AlKhaldi

Swissmedic, SwitzerlandDr. Leonie Rudofsky

TFDA, Chinese TaipeiDr. Fuyu Wu

TGA, AustraliaDr. Deepak Rai

TITCK, TürkiyeSami Akın

Rapporteur Supporter

Ms. Kelly PlueschkeEC, Europe

Alternate

Ms. Inés SammartinoANMAT, Argentina

Ms. Simone Vitoriana de Lima NogueiraANVISA, Brazil

Dr. Rohini HernandezBIO

Dr. Chu-Shu GuHealth Canada, Canada

Ms. Stephanie Hui Wen ChenIFPMA

Ms. Min-Gyo JangMFDS, Republic of Korea

Dr. Xiaona XinNMPA, China

Ms. Mahlodi MoropaSAHPRA, South Africa

Dr. Kathrin EspinozaSwissmedic, Switzerland

Dr. Ching ChenTFDA, Chinese Taipei

Beray YalılıTITCK, Türkiye