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

UsernamePublicRestriction
UsernamePublicRestriction

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.

Advertisement

Related Content

ICH Q11 Redo: Officials Weigh New Approaches for Evaluating Starting Materials
Disagreement over how to justify starting materials selection prompts EMA action
Conflicts over API Starting Materials Persist Despite ICH Q11 Guide

Topics

Advertisement
UsernamePublicRestriction

Register

PS121491

Ask The Analyst

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

All set! This Question has been sent to 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