The International Council for Harmonisation (ICH)
As a Standing Observer of ICH, IFPMA along with other ICH Members and Observers, has an important role in promoting global convergence toward ICH regulatory standards and their harmonized interpretation.
Overview
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a unique platform bringing together regulatory authorities (RAs) and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals, as well as establishing common standards and guidelines.
Implementation of the ICH guidelines supports the alignment of regulatory requirements across regions, reducing duplication of efforts and promoting consistent regulatory standards worldwide. This makes the role of ICH crucial in facilitating the development, registration, and access to safe, effective, and high-quality medicines and vaccines worldwide, contributing to better health outcomes.
Founded in 1990, it was reformed and established as a non-profit legal entity under Swiss Law in October 2015.
How we are contributing to global pharmaceutical standards
The evolving global pharmaceutical regulatory environment and the increasing interest of new countries in joining the ICH highlights the importance of maintaining consistent interpretation and implementation of ICH guidelines among industry and regulatory authorities worldwide. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), along with other ICH Members and Observers, has an important role...
Read moreRepresenting the pharmaceutical industry in ICH
As a Standing Observer of ICH, IFPMA can:
- Attend meetings of the Assembly and the Management Committee (MC) without voting rights
- Nominate up to 2 delegates to attend the meetings of the Assembly and the MC
- Appoint experts to Working Groups (1 expert and 1alternate per WG)
- Appoint an ICH Coordinator
At ICH level, IFPMA represents research-based national or regional pharmaceutical trade associations that operate within the regulatory jurisdiction of one or more ICH Regulatory Members that are outside the European Union, Japan, and the United States.
How we engage
Over 40 IFPMA experts and alternates actively represent IFPMA’s view in more than 20 ICH Expert/Implementation Working Groups (EWG/IWGs) and Discussion Groups (DGs). They collaborate with experts from IFPMA’s different NTAs to provide consolidated input. With their specialized knowledge, experience, and scientific expertise, they contribute to the development of harmonized guidelines focused on quality, safety, efficacy, and multidisciplinary topical areas. Additionally, they play a vital role in developing training materials to facilitate the effective implementation of these guidelines at national and regional levels.
More about the WGs’ progress, work plans and key deliverables please see at ICH Guidelines Webpage.
ICH Assembly and MC Delegates participate in biannual meetings, MC Interim meetings, and regular MC teleconferences, supporting the successful operation of the ICH Assembly and ICH MC.
Ginny Beakes-Read, MC Delegate
Ginny is Vice President, Global Regulatory Policy and Intelligence, Global Regulatory Affairs, at Johnson & Johnson. She leads J&J’s Global Regulatory Policy efforts for the pharmaceutical R&D business, working to improve the regulatory environment to support innovative drug development and patient access to new therapies.
She has extensive experience in regulatory policy, having previously held leadership roles at Amgen, Eisai, and Genentech.
Prior to her industry roles, Ginny was at the Center for Drug Evaluation and Research (CDER) at FDA, where she was the Director, Division of Regulatory Policy II, Office of Regulatory Policy, for 8 years. She was responsible for the development of all regulations affecting CDER and involved with crafting policy positions in areas such as biosimilars.
Before her tenure at FDA, Ginny was a US Army JAG, working as a prosecutor and appellate attorney. Ginny is also an RN and started her career as an intensive care nurse in the US Air Force. Ginny holds B.S.N. and J.D. degrees from the University of Virginia.
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Flavia Firmino, MC Delegate
Flavia Firmino is Director in the Global CMC (Chemistry, Manufacturing & Controls) at Pfizer, based in Brazil, with the role of Regulatory Advisor for Latin America and Africa/Middle East.
She has over 20 years of experience in pharmaceutical industry in quality and regulatory areas and held leadership positions in regulatory conformance, quality operations, and regulatory affairs. Flavia has a wide range of experience in the strategic and tactical aspects of regional regulatory CMC, including CMC-specific knowledge of requirements in Latin America, with a detailed understanding of submission requirements.
Flavia graduated as a pharmacist and has a post graduate degree in Industrial Administration.
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Contributing to global pharmaceutical standards
Discover how IFPMA represents the pharmaceutical industry in ICH and contributes to global pharmaceutical standards.
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