Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

ICH: India, Mexico And Russia Among New Observers; Benefit-Risk Guideline Adopted

This article was originally published in SRA

Executive Summary

India, Mexico, Singapore, South Korea, Russia and Taiwan are among the latest countries to become observers at the International Council for Harmonisation, which has been seeking to establish itself as a 'truly global platform' since undergoing major structural reforms last year1.

You may also be interested in...



ICH Sets Three-Year Goal To Harmonize Criteria For Biowaivers

ICH outlines an ambitious work plan to harmonize the disparate requirements for biowaivers among regulators worldwide; New concept paper and business plan highlight areas of disagreement.

Despite Progress, More Work Needed To Harmonize FDA and EMA Criteria For Biowaivers

While FDA took a big leap forward by waiving bioequivalence studies for BCS Class 3 drugs and aligning biowaiver rules with the EU, there is still work that needs to be done to harmonize solubility and permeability criteria. Until these differences are resolved, pharmaceutical manufacturers may still need to perform separate studies in getting biowaivers approved in these to jurisdictions. This issue is taking on more prominence now as ICH is looking into harmonizing biowaiver requirements worldwide.

ICH Takes Flexible Approach On Presenting Benefit-Risk Assessment In Drug Submissions

The International Council for Harmonisation's final guidance on standardizing benefit-risk information in drug submissions is expected to support regulatory decision-making through a more consistent description of information.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS118710

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel