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M16 – Structured Product Quality Submissions

Guideline number: M16

This topic was endorsed by the ICH Assembly in April 2025, and the M16 Working Group has been established to develop a final Concept Paper.

Endorsed Documents

Ongoing public consultations

No results found.

M16 Expert Working Group

Rapporteur

Dr. Geoffrey WuFDA, United States

Regulatory Chair

Dr. Turki AlhagbaniSFDA, Saudi Arabia

Experts

CPED, IsraelDr. Deborah Benhaim
DIGEMAPS, Dominican RepublicMr. Pablo Juan Decena Perez
DIGEMID, PeruMs. Jessica Cintia Hernández Ávila
DINAVISA, ParaguayDr. Alberto Burgos
DPM, TunisiaDr. Ghadir Jouili
EACMr. Begumisa Nzolo Casmil
EDQMDr. Anthony O'Shea
PPBHK, Hong Kong, ChinaMr. Ho Wing Chung
SAHPRA, South AfricaMr. Lucky Marageni
SRS, El SalvadorMs. Rebeca Ester Gonzáles Villalobos
USPMr. Michael Levy
ANMAT, ArgentinaMs. Ana Carolina Abba
ANVISA, BrazilMr. Marcelo Montenegro Rabello
APICDr. David Voglar
BIODr. Pratiksha Mehta
EC, EuropeMr. Georg Neuwirther
EC, EuropeMr. Marcus Savsek
EDA, EgyptDr. Doha Ismaeel
EFPIAMr. Laurent Lefevbre
EFPIADr. Fabian Schwarb
FDA, United StatesDr. Elvira Argus
FDA, United StatesDr. Bazarragchaa Damdinsuren
Global Self-Care FederationMr. Robert Davies
Health Canada, CanadaMr. Martin Houle
HSA, SingaporeDr. Xuhua Tang
IFPMAMr. Shenqi (Handsome) Ji
IFPMAMs. Daniela Rosa
IGBAMr. Javier Monvoisin
JPMAMr. Taku Watanabe
MFDS, Republic of KoreaMr. Seokmin Song
MHLW/PMDA, JapanMs. Mariko Suzuki
MHLW/PMDA, JapanMs. Hitomi Yoshida
MHRA, UKDr. Fotis Iliopoulos
NMPA, ChinaDr. Xianwei Mi
PhRMADr. Rita Algorri
PhRMAMr. Rodrigo Palacios
Swissmedic, SwitzerlandDr. Alexander Reichenbach
TFDA, Chinese TaipeiDr. Kelly Huang
WHODr. Antony Fake

Rapporteur Supporter

Ms. Hymavathi YanamadalaFDA, United States

Alternate

Dr. Cecilia ParradoANMAT, Argentina
Ms. Daniela Vieira dos Reis SturzeneggerANVISA, Brazil
Ms. Sheetal GaikiAPIC
Ms. Sarah WassmerHealth Canada, Canada
Dr. Peng (Vincent) DuanIFPMA
Dr. Stuart WhittakerIGBA
Ms. Xiaojing LiNMPA, China
Mr. Wen-Hsiu ChiuTFDA, Chinese Taipei