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


Draft ICH Q11 Q&A Guidance Would Clarify Starting Materials Selection

Executive Summary

ICH regulatory members have agreed to request comment on draft Q11 Q&A guidance that is meant to clear up ambiguities on starting materials selection that have fueled debate between industry and regulators for years. The guidance also clarifies the difference between custom-manufactured and commercially available chemicals.

You may also be interested in...

ICH Demystifies Q11 Guide On Selection Of Starting Materials

A new Q&A document finalized by the International Council for Harmonisation aims to clarify and harmonize the information that companies should include in their marketing applications on the selection of starting materials for manufacturing drug substances.

Upcoming ICH Q11 Guide To Clarify What Constitutes Starting Materials

There will be no easy answers on starting materials for drug substance manufacture, an ICH working group is finding. Draft guidance that could come later this year will explain the differences between chemicals that are custom-made and those that are commercially available and is expected to outline in more detail the information needed in submissions for starting materials.

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.





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