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News & Press: Regulatory Updates

PHSS Regulatory Update March 2014

10 March 2014  
Posted by: Tamsin Marshall
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PHSS Regulatory Update March 2014

Introduction

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month most reported issues have come from the EU and USA regulatory authorities.The topics covered in this edition of the "Update” include:

Europe

  • Destruction of Suspected Fake medicines
  • Update on the implementation of the Falsified Medicines Directive
  • Draft Annex 15: Qualification and Validation
  • Risk Based Inspections
  • Changes to Drug Precursor Chemical Regulations

USA

  • Secure Supply Chain Pilot Program
  • Guidance for Industry - Analytical Procedures and Methods Validation for Drugs and Biologics
  • Guidance Documents Planned for Publishing During Calendar Year 2014
  • Guidance Documents Planned for Publishing During Calendar Year 2014
  • Calcium gluconate 10% Injections by Rx Formulations: Recall - Microbial Contamination
  • Another Ranbaxy facility added to existing consent decree

Documents

  • Regulation of medicines and medical devices

International

China

  • Regulations for the Supervision and Administration of Medical Devices

Switzerland

  • Memorandum of Understanding (MOU) with the Republic of Korea on cooperation in the field of therapeutic products

Documents

  • Regulation of medicines and medical devices

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