Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The International Conference on Harmonisation (ICH) has renamed itself as the International Council for Harmonisation (ICH) and has now become a legal entity under Swiss law.
ICH says its changes will help it to expand its membership, which currently includes pharmaceutical regulators from the US, EU, Japan, Canada and Switzerland.
"More involvement from regulators around the world is welcomed and expected … This is matched by the possibility of wider inclusion of global industry sectors affected by ICH harmonization," the council said in a statement on Monday.
Most recently, ICH updated its guideline on Good Clinical Practice, with new specifics on quality management and trial monitoring.
This year marks 25 years of ICH delivering harmonized guidelines on global pharmaceutical development and regulation.
At the end of the inaugural meeting from last week, ICH 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.”
Tags: ICH, PhRMA, EFPIA, PMDA, EMA, FDA