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News & Press: Regulatory Updates

PHSS Regulatory Update March 2013

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update March 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 regulatory authorities plus ICH.

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

Europe

· Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use

· API Listing (Import of active substances)

· EMA and European Commission renew confidentiality arrangement with Canada

· MHRA launches an „Innovation Office

· MHRA implements innovative software to analyse risk data and target inspection activity

· Simplification proposals following "Red Tape Challenge”

USA

· Recommendations for Labelling Medical Products to Inform Users that the Product or Product Container is not made with Natural Rubber Latex

· Draft guidance - Formal dispute resolution appeals above the division level

· Guidance for Industry - Tablet Scoring Nomenclature, Labelling and Data for Evaluation

· Guidance for Industry - Blood Establishment Computer System Validation in the User's Facility

International

· Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – m7

Conferences

· Joint BIA/MHRA Conference: Innovation in the development and regulation of biopharmaceuticals


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