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News & Press: Regulatory Updates

PHSS Regulatory Update July 2012

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update July 2012

INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month all reported issues have come from the EU and USA regulatory authorities.

The topics covered in this edition of the "Update” include:

Europe

· Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use

· Canada becomes an observer to the EU OCABR Network

· Top ten deficiencies in new applications for CEPs (2011)

· CEPs - Help on Submission of Notifications, Revisions and Renewals

· EMA 2011 Annual Report

· Human Medicines Regulations 2012 laid before UK Parliament

USA

· New USP Chapter<1660> Evaluation of the Inner Surface Durability of Glass Containers.

· Listing of Guidance documents

· Guidance for Industry Pyrogen and Endotoxins Testing: Q&A

· Revised requirements for D&C Red No. 6 and D&C Red No. 7

 


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