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

EMA To Update Active Substances Guide To Address Nitrosamine Contamination

Executive Summary

The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions. 

You may also be interested in...



EU Regulators Take A Practical Approach To Addressing Nitrosamine Contamination

Regulators in the EU have decided on specific arrangements they plan to employ if sponsors detect and report nitrosamine impurities in their products being sold on the market.

Simplified Clinical Trial Transparency Rules To Go Live In The EU In June

A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules. 

WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency

The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146843

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