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

More Time For EU Nitrosamine Evaluations Due To COVID-19

Companies Are Allowed Additional Six Months

Executive Summary

Citing challenges posed by the COVID-19 pandemic, EU regulators have extended the deadline for companies to finish nitrosamine-related risk evaluations.

You may also be interested in...



Nitrosamine Testing Policy From European Pharmacopeia’ Largely Aligns With USP

Two groups have issued largely complementary testing methods for measuring nitrosamine impurities in drugs, and the differences that do exist are “insignificant,” EDQM official advises. The two are working to further harmonize testing standards, given the global scope of the nitrosamine scare.

Europe Stands Firm On Nitrosamine Assessment Deadline For APIs

The European Directorate for the Quality of Medicines & HealthCare says it will not extend the deadline for nitrosamine-related risk assessment of active substances even though an extension is in place for assessments of finished products.

Companies Get Yet More Time To Assess Nitrosamine Risk In EU

After EU regulators decided that biological medicines should be reviewed for the presence of possible nitrosamine impurities – as is already required for chemical medicines – new deadlines have been agreed on to give companies enough time to comply.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS141947

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