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

Europe in Brief

This article was originally published in The Gold Sheet

Executive Summary

More objections to EU GMP requirements for active substances; clarification of import requirements under FMD; new GMP guides incorporate ICH Q10.

You may also be interested in...



Worldwide Regulatory Inaction on FMD May Result in Drug Shortages

There could be the potential of drug shortages in the EU unless more countries certify that drug substances made within their borders are equivalent to EU GMP standards, say pharmaceutical industry and EU health authorities. Many regulators are sitting on the sidelines and have taken no action to comply with FMD’s import provisions for active substances, which goes into effect in July.

With July 2013 Deadline Looming, Debate Continues Over How to Require GMPs for APIs in Europe

As Europe prepares to subject API imports to GMP controls, industry urges a different approach. Questions linger over how to keep Anti-Falsification Directive from drying up Europe’s API supplies.

The Anti-Falsification Directive: Europe’s Answer to Global Supply Chain Threats

The European Union July 1 published its directive on falsified medicines, setting into motion a tightening of Europe’s pharmaceutical supply chain that will for the most part take place over the next 18 months – and that could cost pharmaceutical companies billions of Euros.

Latest News
See All
UsernamePublicRestriction

Register

PS000712

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