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The ICH Steering Committee (SC) established in April 1990, when ICH was initiated. The Steering Committee, working within the ICH Terms of Reference, determines the policies and procedures for ICH, selects topics for harmonisation and monitors the progress of harmonisation initiatives. The Steering Committee also oversees the preparations for the series of International Conferences on Harmonisation, which have been held biannually since 1991. The ICH Steering Committee has two Members from each of the six ICH parties (EU, EFPIA, MHW, JPMA, FDA , PhRMA) as well as IFPMA. Representatives of WHO, EFTA and Canada are nominated as Observers on the Steering Committee (see also, Structure of ICH)
The Committee is chaired by one of the regulatory parties and the Chair is rotated, according to the country in which the SC meeting takes place. The Committee normally meets twice a year, with additional meetings in Conference years.
ICH Coordinators for the six ICH parties, and the ICH Secretariat provide administrative support for the Steering Committee.
On technical issues, the Steering Committee is advised by Expert Working Groups
Prof. J. M. Alexandre | Chairman, Committee for Proprietary Medicinal Products (CPMP)
The European Agency for the Evaluation of Medicinal Products, EMEA (Directeur de l'Evaluation, Agence Française du Médicament, France) |
Mr Patrick Deboyser | Head of Unit, Pharmaceuticals DGIII/E/3, European Commission, Brussels |
Mr Brian Ager | Director General EFPIA, Brussels |
Dr. Yves Juillet | Pharma Policy Director Roussel Uclaf, France <Top of page> |
Mr Yasunori Tsuruta | Director, Pharmaceuticals and Cosmetics Division Pharmaceutical Affairs Bureau, MHW, Japan |
Mr Kyozo Inari | Project Manager for Clinical Trials Pharmaceutical Affairs Bureau MHW, Japan |
Mr Kazutaka Ichikawa | Senior Managing Director JPMA, Tokyo, Japan |
Mr. Osamu Ebi | Member of the Board Regulatory Affairs Takeda Chemical Industries, Ltd, Japan <Top of page> |
Dr Roger L. Williams | Associate Director, Science and Medical Affairs Center for Drug Evaluation & Research (CDER), FDA, USA |
Dr. Elaine C. Esber | Associate Director for Medical and International Affairs Center for Biologics Evaluation and Research (CBER), FDA, USA |
Dr John Beary | Senior Vice President for Regulatory and Scientific Affairs PhRMA, Washington, USA |
Dr. Alexander Giaquinto | Senior Vice President Worldwide Regulatory Affairs Schering Plough Research Institute, Kenilworth, NJ, USA <Top of page> |
Dr. Richard B. Arnold | Executive Vice President IFPMA, Geneva |
Miss Margaret C. Cone | Vice President for Scientific Affairs IFPMA, Geneva |
Dr J. Idänpään-Heikkilä | Director Division of Drug Management & Policies World Health Organization, Geneva |
Ms. Mary Carman | Director Bureau of Pharmaceutical Assessment Drugs Programme, Health Canada |
Dr Rolf Spang | Vice Director, Head Registration Department
Intercantonal Office for the Control of Medicines, Switzerland |
Each of the six co-sponsors has nominated an ICH Coordinator to act as the main contact point with the ICH Secretariat and ensure that ICH documents are distributed to the appropriate persons within the area of their responsibility.
Each party has also established a Contact Network of experts within their own organisation or region in order to ensure that, in the discussions, they reflect the views and policies of the co-sponsor they represent. The organisation of this communication differs according to the administrative structure of the party concerned.
Ms Marie Donnelly | Administrator, DGIII/E/3, Pharmaceutical Unit European Commission, Brussels |
Technical Coordinator Prof. Dr. Rolf Bass |
Head of Unit "Evaluation of Human Medicines" The European Agency for the Evaluation of Medicinal Products (EMEA), London |
Ms Emer Cooke | Manager Scientiifc and Regulatory Affairs EFPIA, Brussels |
Dr Toshiyoshi Tominaga | Deputy Director Pharmaceuticals and Cosmetics Division Pharmaceutical Affairs Bureau, MHW, Japan |
Mr Toshikazu Yoshinaga | Vice Director, Medical &Scientific Department JPMA, Tokyo |
Ms Janet Showalter | FDA's ICH Programme Coordinator Office of Health Affairs, FDA, USA |
Mrs Carol McCullough | ICH Coordinator PhRMA, Washington, USA |
The ICH Secretariat is provided by IFPMA, Geneva. The role is primarily concerned with preparations for, and documentation of, meetings of the Steering Committee as well as coordination of preparations for EWG meetings and six-party drafting groups. At the time of ICH Conferences, the Secretariat is responsible for the technical documentation and for liaison with the speakers for the Conference itself.
Miss Margaret C. Cone | Vice President for Scientific Affairs IFPMA, Geneva |
Mr Katsuji Sato | ICH and Japan Liaison Executive, ICH Secretariat c/o IFPMA, Geneva |
Mrs Sarah Préperier | Secretary, ICH Secretariat, c/o IFPMA, Geneva |
ICH Secretariat
c/o IFPMA
30 rue de St-Jean
P.O. Box 9
1211 Geneva 18
Switzerland
Tel: +41 (22) 340 12 00
Fax: +41 (22) 345 82 75
E-mail:
ich@ifpma.org
The ICH Expert Working Groups are joint regulatory/industry Working Groups for which experts are nominated from the six co-sponsors of the Conference. The Working Groups deal with individual harmonisation Topics and each party nominates a Topic Leader for the subject under discussion. For an ICH EWG to meet formally, on ICH business, there must be at least one expert present from each of the six parties: the Topic Leader, Deputy Topic Leader or nominated representative.
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