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M7 Addendum – Risk Assessment and Control of Nitrosamine Impurities

Guideline number: M7 Addendum

This topic was endorsed by the ICH Assembly in June 2024 and the M7 Sub-group has been established to develop an addendum to the M7 Guideline on Assessment and Control of DNA Reactive (mutagenic) Impurities to address safety assessment and establishment of appropriate controls for nitrosamine impurities.

Endorsed Documents
M7 Sub-group Concept Paper
M7 Sub-group Work Plan

Ongoing public consultations

No results found.

M7 Sub-group

Rapporteur

Dr. Krista DoboPhRMA

Regulatory Chair

Dr. Alisa VespaHealth Canada, Canada

Experts

ANMAT, ArgentinaMs. Melina Dal Mas
ANVISA, BrazilDr. Aline Siqueira Ferreira
APICDr. Filip De Bock
BIODr. Christian Wetter
CECMED, CubaDr. Ámbar Nery González Farah
EC, EuropeDr. Robert Bream
EC, EuropeDr. Roland Froetschl
EC, EuropeDr. Maryam Mehmandoust
EC, EuropeDr. Marianne Schmidt
EDA, EgyptDr. Ola El-Houssini
EDQMMs. Ekaterina Nagdiyev
EFPIADr. Jim Harvey
EFPIADr. Joerg Schlingemann
FDA, United StatesDr. Kelly Brant
FDA, United StatesDr. Sruthi King
FDA, United StatesDr. Andre Raw
Global Self-Care FederationDr. Susan Felter
Health Canada, CanadaDr. Stephen Horne
IFPMAMr. Wenlong Qiu
IGBADr. Lance Molnar
IGBADr. Dhanya Nair
IPECDr. Ulrich Reichert
JFDA, JordanMs. Yumon Hamad
JPMADr. Kiyohiro Hashimoto
JPMADr. Yusuke Nagato
MFDS, Republic of KoreaMs. Minkyung Kim
MHLW/PMDA, JapanDr. Junichi Fukuchi
MHLW/PMDA, JapanDr. Keiji Hirabayashi
MHLW/PMDA, JapanDr. Katsuyoshi Horibata
MHRA, UKMr. Ross Hawkes
MHRA, UKDr. Leonardo Maugeri
NMPA, ChinaDr. Lei Ma
NPRA, MalaysiaDr. Hong Heng See
PhRMADr. Joel Bercu
Roszdravnadzor, RussiaMr. Roman Galeyev
SFDA, Saudi ArabiaMr. Hassan Alshehri
Swissmedic, SwitzerlandDr. Anja Langenkamp
TFDA, Chinese TaipeiDr. Chia-Wei Chou
TGA, AustraliaDr. Yanni Chin
USPMr. Naiffer Romero
WHODr. Isabel Ortega Diego

Rapporteur Supporter

Dr. Jared FennellPhRMA

Alternate

Ms. Carolina KrahnANVISA, Brazil
Dr. Mark PowleyBIO
Mr. Eric ZuoIFPMA
Dr. Zhixing ZhouNMPA, China
Mr. Robert JollyPhRMA
Dr. Anja Maria MöllerSwissmedic, Switzerland
Dr. Pradeep Chandra KumarTGA, Australia
Dr. Mrunal JaywantUSP

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