Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


ICH Q11 Redo: Officials Weigh New Approaches for Evaluating Starting Materials

This article was originally published in The Gold Sheet

Executive Summary

The pharmaceutical industry and regulators are wrangling yet again over what constitutes a starting material. While some are anticipating that an upcoming ICH question-and-answer document will clarify this question, others are suggesting that now may be a good time to resurrect some concepts from an earlier FDA guidance on starting materials that has since been withdrawn.


Related Content

EMA Clarifies That CEPs Can Be Used To Justify Starting Materials Under ICH Q11
Upcoming ICH Q11 Guide To Clarify What Constitutes Starting Materials





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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