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News & Press: Regulatory Updates

PHSS Regulatory Update October 2013

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update October 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, USA, PIC/s and WHO regulatory authorities.

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

Europe

· Q&A - Practical implementation guidelines on variations

· EU GMP Chapter 2 – personnel

· Improving the safety of medical devices

· Can a single system simplify reporting of incidents to the MHRA?

· Proposed introduction of tell-and-do variations for a specificsubset of parallel import licenses

USA

· Proposed regulation to implement administrative detention authority during inspection of drugs intended for human or animal use

· Draft Guidance for Industry - Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration

· Unique Device Identification (UDI)

· Notice to Industry: FDA Launches Secure Supply Chain Pilot Program

PIC/s

· Hong Kong Pharmacy and poisons Board applies for PIC/S membership

WHO

· Good trade and distribution practices for pharmaceutical starting materials. (revision)

Products

· Cervarix – cervical cancer vaccine

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