ICH announces organisational changes as it marks 25 years of successful harmonisation
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly [and Management Committee] on 23 October 2015.
The reforms build on a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development, and their regulation. The changes announced today build on that success and will reinforce the foundations of ICH to make it better-equipped to face the challenges of global pharmaceutical development and regulation.
The reforms will mean that ICH is a truly global initiative, expanding beyond the current ICH members. More involvement from regulators around the world is welcomed and expected, as they will be invited to join counterparts from Europe, Japan, USA, Canada and Switzerland as ICH regulatory members. This is matched by the possibility of wider inclusion of global industry sectors affected by ICH harmonisation. The reforms strengthen ICH as the leading platform for global pharmaceutical regulatory harmonisation, and one that brings together in a transparent manner all key regulatory authorities and industry stakeholders.
The changes give ICH a more stable operating structure through the establishment of an ICH association, a legal entity under Swiss law. The association establishes the new Assembly as the over-arching governing body that will be instrumental in facilitating future growth through the participation of new members.
At the end of the inaugural meeting, ICH Assembly members declared “The fundamentals of what the ICH parties are trying to achieve are not changed, but the reforms to the process and organisation were needed to adapt to changes in how medicines are developed and regulated. These changes mark an exciting moment for us to help harmonise and streamline the global drug development process for the benefit of patients around the world.”
For further information, please contact the ICH Secretariat at pressrelease@ich.org.
About IFPMA
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents over 90 innovative pharmaceutical companies and associations around the world. Our industry’s almost three million employees discover, develop, and deliver medicines and vaccines that advance global health. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community improve the lives of people everywhere. For more information, visit ifpma.org.
Learn more
Related news and resources
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 more
Regulatory agilities applied to vaccines during the COVID-19 pandemic and recommendations for the future
This position paper outlines some key regulatory agilities implemented in areas such as research and development, regulatory evaluations, authorizations, and post-approval changes (PACs) and labelling. Key learnings and recommendations to enhance regulatory frameworks in the future are also included.
Read more
Lessons from regulatory agilities during the COVID-19 pandemic: views from members of National Regulatory Authorities
This report aims to explore the perspective of members of NRAs on the use of regulatory agilities which emerged during the COVID-19 pandemic and describe lessons learnt from this experience.
Read more