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News & Press: Regulatory Updates

PHSS Regulatory Update December 2012

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

INTRODUCTION

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

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

Europe

· EMA reviews its operations and prepares for reorganisation in 2013

· EMA to focus on implementation of new legislation, / increase of efficiency and transparency

· Swiss GMP and inspection standards for API considered equivalent to those of the EU

· Human and Veterinary Official Control Authority Batch Release Guidelines

· New webpage on "Actions on CEPs"

· Changes affecting company authorisations and new registrations of companies

· Change of ownership applications

· Notification of imminent request for active substance information

· Q&As from the falsified medicines directive MHRA/industry meeting held 15 November

· Consultation on the MHRA draft 2013 – 2018 corporate plan

USA

· Important change to heparin container labels to clearly state the total drug strength

PIC/s

· Revised PIC/S GMP Guide

Products

· 32mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron product


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