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News & Press: Regulatory Updates

PHSS Regulatory Update July 2015: Annex 21 Guidance for Importers; MHRA Info; ICH Q7 and more

08 July 2015   (0 Comments)
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 and USA and Swiss regulatory authorities plus ICH. The topics covered in this edition of the “Update” include:

Europe

  • Concept paper- guidance for importers of medicinal products (new Annex 21)
  • MHRA to fully adopt use of the common repository for centralised procedures.
  • New MHRA Inspectorate blog
  • MHRA helps to future-proof mammalian cell culture manufacturing facility.
  • MHRA 2015/16 business plan
  • EU GDP guidelines valid in Switzerland

 USA

  • Allowable Excess Volume and Labelled Vial Fill Size in Injectable Drug and Biological Products
  • Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
  • Naming of Drug Products Containing Salt Drug Substances
  • Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products
  • USP <671> Containers—Performance Testing: Use of Water-Filled Test Containers for Water Vapor Transmission Rate Determinations

International

ICH

  • ICH Q7 Q&As

Products

  • Many addictive drugs lacked statutory packaging seal

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