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News & Press: Regulatory Updates

PHSS Regulatory Update June 2015 : GVK Biosciences: International regulatory cooperation (GMP): DNA

25 June 2015  
Posted by: Tamsin Marshall
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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 Indian regulatory authorities.

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

Europe

EMA

  • Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups

USA

  • Providing regulatory submissions in electronic format
  • Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms
  • ANDA Submissions – Refuse-to-Receive Standards
  • Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
  • Reportable CMC Changes for Approved Drug and Biologic Products
  • Draft guidance on animal drug compounding from bulk drug substances

International

India

  • Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments.

PIC/S

  • Strengthening of international regulatory co-operation in the field of GMP.
  • PIC/S Inspectors Academy. (PIA)
  • Membership Updates

Products

  • GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed studies

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