After some intense internet search I can't seem to find a the most current version or draft of the Q10. The ICH website list only up to Q9, on the other hand the internet is full of conferences being held to discuss the interpretation and implementation of this guideline. A guideline I do not beleive has been published. The internet is also full of Powerpoint presentations on it, but not one has a link to this document. Can anyone please link me to the latest draft???

Thanks,

Jim

Hmmm... From the site: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

The objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health. This Mission is embodied in the Terms of Reference of ICH.

Interesting - First time I've been to that web site. I'd have thought others here who are into pharmaceuticals might have some feedback.