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News & Press: Regulatory Updates

PHSS Regulatory Update June 2012

28 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update June 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 Brazilian and Chinese regulatory authorities.

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

Europe

  • Compilation of Community Procedures on Inspections and Exchange of Information –Revision 14 May 2012
  • Foundation of a new French Health Regulation Authority ANSM
  • e-TACT Round-table Discussion on "Identifying falsified medicines: How best to protect European citizens?”
  • 17th Annual Meeting of the European Network of Official medicines control laboratories (OMCLs)Xxx

USA

  • FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus
  • Draft Revised Amendment to Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products
  • Thiomersal in vaccines

China

  • Draft excipient guidelines

Brazil

  • Proposal for a normative act that regulates GMP for Pharmaceutical Excipients.


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