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Q5E Annex – Comparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their Manufacturing Process

Guideline number: Q5E Annex

This topic was endorsed by the ICH Assembly in April 2025, and the Q5E Annex Working Group has been established to develop a final Concept Paper.

Endorsed Documents
Q5E Annex Concept Paper
Q5E Annex Work Plan

Ongoing public consultations

No results found.

Q5E Annex Expert Working Group

Rapporteur

Dr. Kathleen FrancissenBIO

Regulatory Chair

Dr. Andrew TimmonsFDA, United States

Experts

DIGEMID, PeruRolando Vega Zúñiga
TITCK, TürkiyeMs. Kübra Ekinci
USPDr. Ben Clarke
ANMAT, ArgentinaMs. Gabriela Bravo
ANVISA, BrazilDr. Melina Kumoto
BIODr. Michael DeFelippis
BIODr. Gillian Payne
CPPS, UzbekistanMr. Mirsodikjon Nazarkulov
DPM, TunisiaDr. Imen Ben Mansour
EC, EuropeDr. Andreea Barbu
EC, EuropeDr. Jan Mueller-Berghaus
EDA, EgyptDr. Hebatalla Ibrahim
EDQMDr. Olga Kolaj-Robin
EFPIADr. Florence Salmon
FDA, United StatesDr. Saravanan Karumbayaram
FDA, United StatesDr. Eric Levenson
Health Canada, CanadaDr. Omar Tounekti
HSA, SingaporeDr. Ying Zhang
IFPMADr. Fong Chan Choy
IFPMAMs. Erika Diago Rufino
IGBADr. Sameer Deshmukh
IGBADr. Kyu Eui Kim
JFDA, JordanDr. Suna Habahbeh
JPMADr. Nao Nakamura
MFDS, Republic of KoreaDr. Jin Wook Kang
MHLW/PMDA, JapanMr. Atsushi Nishikawa
MHLW/PMDA, JapanDr. Satoshi Yasuda
NMPA, ChinaDr. Wei Wei
PhRMAMs. Lesbeth Rodriguez
Roszdravnadzor, RussiaDr. Ekaterina Melnikova
SAHPRA, South AfricaDr. Henry Martin Leng
SRS, El SalvadorMr. Luis Enrique Álvarez Mirón
Swissmedic, SwitzerlandDr. Petra Minder
TFDA, Chinese TaipeiDr. Wern-Chir Liao

Rapporteur Supporter

Ms. Elaine ShultsBIO

Alternate

Dr. Mariano SaboridoANMAT, Argentina
Ms. Lara Cristina PereiraANVISA, Brazil
Dr. Sibylle HerzerEFPIA
Dr. Martin NemecHealth Canada, Canada
Dr. Lei ZhangIFPMA
Dr. Dana AhmadJFDA, Jordan
Dr. Su Kyoung SeongMFDS, Republic of Korea
Dr. Jiaqi LuNMPA, China
Christina IvesPhRMA
Dr. Petra Kempna BukovacSwissmedic, Switzerland
Dr. Chun-Han HoTFDA, Chinese Taipei

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