Home / Guidelines & Products

S13 – Nonclinical Safety Studies for Oligonucleotide-based Therapeutics

Guideline number: S13

This topic was endorsed by the ICH Assembly in June 2023, and an Expert Working Group (EWG) has been established to develop a final Concept Paper.

Endorsed Documents

Ongoing public consultations

No results found.

S13 Expert Working Group

Rapporteur

Dr. Susanne Brendler-SchwaabEC, Europe

Regulatory Chair

Dr. Yoko HirabayashiMHLW/PMDA, Japan

Experts

Health Canada, CanadaMr. Nick Orphanos
ANMAT, ArgentinaDr. Mercedes Ferrando
ANVISA, BrazilMs. Kellen Christina de Freitas Gissoni
BIODr. Patrik Andersson
BIODr. Prasad Nadella
EC, EuropeMr. Florian Koban
EC, EuropeMs. Christine Siezen
EDA, EgyptDr. Heba Mansour
EFPIADr. Timothy MacLachlan
EFPIADr. Joel Parry
FDA, United StatesDr. Elena Braithwaite
FDA, United StatesDr. Xuan Chi
HSA, SingaporeDr. Alvin Chia
IFPMADr. Xuelian Gong
JPMADr. Koichi Goto
JPMADr. Yuichi Takai
MHLW/PMDA, JapanDr. Mahiro Egashira
MHLW/PMDA, JapanDr. Takasumi Shimomoto
MHRA, UKDr. Roshni Desai
NMPA, ChinaDr. Huajing Yin
PhRMADr. Tod Harper
SFDA, Saudi ArabiaDr. Ibrahim G. Al Gayadh
Swissmedic, SwitzerlandMs. Andreas Marti
TFDA, Chinese TaipeiMr. Peter Fan

Rapporteur Supporter

Ms. Ciska van Doesum-WoltersEC, Europe

Alternate

Dr. Maria Laura CladouchosANMAT, Argentina
Mr. Andrew GravesIGBA
Dr. Na NingNMPA, China
Dr. Jennifer SislerPhRMA
Ms. Eloise KremerSwissmedic, Switzerland
Dr. Mei-Huei NiTFDA, Chinese Taipei