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News & Press: Regulatory Updates

PHSS Regulatory Update January 2015

09 January 2015   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update January 2015  

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.

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

Europe

  • Mitigating risks due to the use of antibiotics in animals
  • Adaptive pathways: a future approach to bring new medicines to patients?
  • Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council. GMP for active substances for medicinal products for human use.
  • UK Department of Health  triennial review of “arms length Bodies” (including MHRA)

USA

  • Product Tracing Requirements Compliance Policy - Guidance for Industry
  • DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers - Guidance for Industry
  • How to Obtain a Letter from FDA Stating that Bioequivalence  Study Protocols Contain Safety Protections Comparable to  Applicable REMS for RLD - Guidance for Industry
  • Infusion Pumps Total Product Life Cycle Guidance for Industry and FDA Staff
  • Conclusions of FDA-EMA Parallel Assessment of Quality-By-Design Elements of Marketing Applications

Products

  • First stem-cell therapy recommended for approval in EU
  • “Accidental” administration of trial materials to patients.

RECENT DEVELOPMENTS IN GMP AND REGULATORY REQUIREMENTS


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