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News & Press: Regulatory Updates

PHSS Regulatory Update May 2012

28 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update May 2012

INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month a significant number of reported issues have come from the UK MHRA, two which are UK responses to Delegated Acts and European Commission documents. These comments reflect the UK MHRA’s concerns with the proposals.

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

Europe

  • Revised guideline on quality of biosimilar medicines
  • Guideline on quality of biological active substances produced by transgene expression in animals
  • Questions and answers on post approval change management protocols
  • 142nd session of the European Pharmacopoeia Commission
  • Reflection paper on classification of advanced therapy medicinal products
  • UK response - Delegated act on the detailed rules for a unique identifier for medicinal products, and its verification
  • MHRA launches new anticounterfeiting strategy
  • Supply of medicines by pharmacy to healthcare professionals
  • GMP deficiency data review  UK comments on the European Commission’s draft template for the written confirmation for active substances imported into the European Union
USA
  • Amendments to Sterility Test Requirements for Biological Products
International
  • TGA medicine labelling and packaging review
  • Development and Manufacture of Drug Substances ICH Q11
  • PIC/S meeting
Documents
  • PDA TR 30 Parametric release of pharmaceutical products and medical devices terminally sterilized by moist heat  Rx-360 publishes 3 new audit checklists

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