The Global Cooperation Group (GCG) was originally formed as a subcommittee of the ICH Steering Committee in 1999 in response to a growing interest in ICH Guidelines beyond the three ICH regions. A few years later, recognising the need to engage actively with other harmonisation initiatives, representatives from five Regional Harmonisation Initiatives (RHIs) were invited to participate in GCG discussions, namely, APEC, ASEAN, EAC, GCC, PANDRH and SADC. A further expansion of the GCG was agreed in 2007 and regulators were invited from countries with a history of ICH Guideline implementation and/or where major production and clinical research are done (Australia, Brazil, China, Chinese Taipei, India, Republic of Korea, Russia and Singapore).

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GO

EU

Ms. Lenita Lindström

Job Title:Senior Policy Officer
Pharmaceutical Unit
Address:Directorate General for Health and Consumers
European Commission
Brussels, Belgium

EFPIA (Co-Chair)

Dr. Sabine Luik

Job Title:Sr. Vice President
Medicine & Regulatory Affairs
US Regional Medical Director
Address:Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, Connecticut

MHLW

Mr. Naoyuki Yasuda

Job Title:Director
International Planning
Address:Ministry of Health, Labour & Welfare (MHLW)
Tokyo, Japan

JPMA

Dr. Hironobu Saito

Job Title:Vice President
New Drug Regulatory Affairs Department
R&D Center
Address:Daiichi Sankyo Co., Ltd.
Tokyo, Japan

FDA (Co-Chair)

Dr. Justina A. Molzon

Job Title:Associate Director
International Affairs
Address:Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)
Silver Spring, MD, USA

PhRMA

Dr. Peter K. Honig

Job Title:Head Global
Regulatory Affairs
Address:AstraZeneca
Wilmington, DE, USA

IFPMA

Mr. Eduardo Pisani

Job Title:Director General
Address:International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Geneva, Switzerland

Dr. Odette Morin

Job Title:Director
Regulatory & Scientific Affairs
Address:International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Geneva, Switzerland

Health Canada

Mr. Mike Ward

Job Title:Manager
International Programs Division
Address:Bureau of Policy and Coordination Therapeutic Products Directorate, Health Products and Food Branch, Health Canada
Ottawa, Canada

WHO

Dr. Lembit Rägo

Job Title:Coordinator
Quality Assurance and Safety: Medicines Health Technology & Pharmaceuticals (HTP/EDM/QSM)
Address:World Health Organization (WHO)
Geneva, Switzerland

EFTA

Dr. Petra Doerr

Job Title:Head of Management Services and Networking
Address:Swissmedic, Swiss Agency for Therapeutic Products
Bern, Switzerland

APEC

Ms. Barbara Norton

Job Title:LSIF Planning Group Chair
Director, Industry
Address:Office of United States Trade Representative (USTR)
Washington DC, USA

ASEAN

Dr. Yuppadee Javroongrit

Job Title:Co-Chair of ASEAN ACCSQ PPWG
Assistant Director & Head of International Affairs & IND Section
Drug Control Division
Address:Food and Drug Administration, Ministry of Public Health
Nonthaburi, Thailand

EAC

Ms. Jane H. Mashingia

Job Title:Senior Medicines and Food Safety Officer
Address:East African Community (EAC)
Arusha, Tanzania

Dr. Kipkerich Chumo Koskei

Job Title:Registrar
Pharmacy & Poisons Board
Address:Ministry of Health
Nairobi, Republic of Kenya

GCC

Prof. Saleh Bawazir

Job Title:Vice-President
Head of Drug Sector
Address:Saudi Food and Drug Authority (SFDA)
Riyadh, Saudi Arabia

PANDRH

Dr. James Fitzgerald

Job Title:Coordinator
Essential Medicines and Biologicals Project Area of Technology, Health Care, and Research
Address:Pan American Health Organization (PAHO)
Washington DC, USA

SADC

Mr. Joseph Mthetwa

Job Title:Senior Programme Manager
Health and Pharmaceuticals Directorate on Social and Human Developmentand Special Programmes
Address:Southern African Development Community (SADC)
Gaborone, Botswana

DRA of AUSTRALIA

Dr. John Donohoe

Job Title:Director
Management Coordination Office of Prescription Medicines
Address:Therapeutic Goods Administration
Woden, Australia

DRA of BRAZIL

Dr. Dirceu Brás Barbano

Job Title:Acting Director
Address:Brazilian National Health Surveillance Agency (ANVISA)
Brasilia DF, Brazil

Mrs. Ana Paula Soares Juca da Silveira e Silva

Job Title:Head of the Unit for International Sanitary
Address:Brazilian National Health Surveillance Agency (ANVISA)
Brasilia DF, Brazil

DRA of P.R. CHINA

Dr. Chen Zhen

Job Title:Director
Office of New Drug of Pharmaceutical Science
Center for Drug Evaluation
Address:China Food and Drug Administration
Beijing, P.R. China

Mr. Zhang Wei

Job Title:Director General
Department of Drug Registration
Address:China Food and Drug Administration
Beijing, P.R. China

DoH of CHINESE TAIPEI

Dr. Meir-Chyun Tzou

Job Title:Director
Division of Drug and New Biotechnology Product
Address:Food and Drug Administation, Department of Health
Taipei City, Chinese Taipei

Dr. Churn-Shiouh Gau

Job Title:Executive Director
Center for Drug Evaluation
Address:Food and Drug Administration, Department of Health
Taipei City, Chinese Taipei

DRA of INDIA

Dr. Gyanendra Nath Singh

Job Title:Drugs Controller General
Address:Directorate General of Health Services, Central Drugs Standard Control Organization
New Delhi, India

DRA of KOREA

Dr. Sun Hee Lee

Job Title:Director General
Drug Evaluation Department
Address:Korea Food & Drug Administration (KFDA)
Chungbuk, Republic of Korea

Ms. Eun Hye Park

Job Title:Reviewer & Scientific Officer
Drug Evaluation Department
Address:Korea Food & Drug Administration (KFDA)
Chungbuk, Republic of Korea

DRA of SINGAPORE

Dr. Christina Lim

Job Title:Senior Director
International Relations
Health Products Regulation Group
Address:Health Sciences Authority
Singapore

Dr. Dorothy Toh

Job Title:Director
Vigilance and Compliance Division
Health Product Regulation Group
Address:Health Sciences Authority
Singapore

Quote

 

If you want to go fast, go alone. If you want to go far, go together.

African Proverb