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 Says Nitrosamine Risk Info Also Needed For New Drug Filings

Incomplete Info May Impact Granting Of Marketing Authorization

Executive Summary

Companies seeking approval of new drugs must provide information on nitrosamine-related risk evaluation either as part of their marketing application or during the evaluation process.

You may also be interested in...



The Quality Lowdown: Warning Letters, Nitrosamine Recalls And Sen. Warren's Generics Manufacturing Plan

Manufacturers warned on quality basics like testing and keeping records and reminded about nitrosamine deadlines; Senator Elizabeth Warren clarifies government drug manufacturing idea.

Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators

EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.

Centralized Templates To Help Harmonize Trial Dossiers Requirements Across The EU

Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS141478

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