Pink Sheet is part 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


EMA Clarifies That CEPs Can Be Used To Justify Starting Materials Under ICH Q11

Executive Summary

EMA has issued a revised reflection paper that clarifies where in the CTD information on starting materials should go and says that manufacturers can submit certificates of suitability for justifying their use of starting materials under ICH Q11.

You may also be interested in...

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

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may be a good time to resurrect some concepts from an earlier FDA guidance on starting materials that has since been withdrawn.

Disagreement over how to justify starting materials selection prompts EMA action

The European Medicines Agency is attempting to clarify what information drug companies should include in their marketing authorization dossiers to justify the selection of starting materials in light of 2012 International Conference on Harmonisation guideline Q11 that covers this topic.

Conflicts over API Starting Materials Persist Despite ICH Q11 Guide

API manufacturers in the U.S. and the EU say the ICH Q11 guidance lacks specific direction on when chemicals become starting materials, and as a result there are differing interpretations on designation among regulators. A member of ICH Q11 group advised industry to focus on supply chain, not steps.





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