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News & Press: Regulatory Updates

PHSS Regulatory Update November 2013

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

INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month the number of reported items from the USA has probably been affected by the government shutdown. It is worrying to see yet another report from USFDA of lack of sterility of product made in a compounding pharmacy.

The topics covered in this edition of the ―Update include:

Europe

· EMA to publish agendas and minutes of all committees

· 8th Edition of the European Pharmacopoeia

· The Council of Europe steps up action worldwide with the Medicrime Convention

· Falsifed Medicines Directive (MHRA)

· Nicotine containing products(MHRA)

· Q&A for Specials manufacturers (MHRA)

USA

· Draft guidance for Industry – Refuse-to- Receive standards

· Bacterial Endotoxins Test

· Guideline For Elemental Impurities

International

Australia

· Launch of the Medical Device Single Audit Program (MDSAP) Pilot

PIC/S

· PIC/S meeting and annual training seminar

South Africa

· South Africa joins the European Pharmacopoeia

Products

· Budesonide solution from The Compounding Shop

· MHRA issues Class 2 recall notice for multiple products from a 2nd Wockhardt India site

Documents

· Interpretation of EU GDP Guidelines

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