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News & Press: Regulatory Updates

PHSS Regulatory Update February 2013

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update February 2013

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 and USA & WHO regulatory authorities.

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

Europe

· European Union - Israel Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA)

· Guideline - porcine trypsin used in the manufacture of human biological medicinal products

· Guideline for comment - GMP for Excipients

· Import of active substances Q & A v3

USA

· Collaboration in Managing the CDER Drug Quality Oversight Program MAPP 4151.15

· New & revised guidances 2013

· FDA seeks listing under EU Falsified Medicines Directive

· Inspection of speciality compounding pharmacies

International

· Proposed update of WHO GMP

Products

· Diane 35 and generics used in the treatment of acne

· Final testing results for PIP implants published


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