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

EU Offers Practical Guide To Help Pharma With Nitrosamine Evaluations

Guide Explains Steps Needed For Risk Evaluations And Confirmatory Testing

Executive Summary

The EU guide covers medicines authorized at the national level and under the mutual recognition and decentralized procedures.

You may also be interested in...



Australia Finds ‘Unacceptable’ Levels Of NDMA In 80% of Ranitidine Batches

Testing carried out by Australia's drug agency on batches of 34 ranitidine products marketed by 10 different sponsors has found high levels of NDMA contamination in the vast majority of cases. The agency is now considering tightening its oversight of all ranitidine drugs sold in Australia. 

EMA Identifies Potential Sources Of Nitrosamine Contamination

As companies evaluate scores of products for the possible presence of nitrosamine impurities, the EU regulator has listed potential sources of contamination identified to date to help sponsors develop a risk-based approach for their evaluations.

EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141107

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