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News & Press: Regulatory Updates

PHSS Jan 2018 Reg Update: Brexit preparations; Annex 1 consultation; Gluten in drug products

10 January 2018   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update January 2018


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 China,the EU, Swiss, USA & PIC/s regulatory authorities

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




  •  Procedural guidance to help pharma companies prepare for Brexit
  •  Consultation on the revision of annex 1, on manufacturing of sterile medicinal products
  •  European Commission closes infringement procedure against Roche
  • Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
  • Annual report of the GMP/GDP Inspectors Working Group 2016
  • First guidance on monoclonal antibodies for use in animals
  • MHRA GDP inspection deficiency data for 2016
  • MHRA GPvP Inspection Metrics for April 2016 to March 2017



  • Gluten in drug products and associated labeling recommendations 

  •  Refuse to File: NDA and BLA submissions to CDER

  •  Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs

  • Drug Products, including biological products, that contain nanomaterials

  •  Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

  •  Best practices for communication between IND sponsors and FDA during drug development 



  • Modified-release paracetamol-containing products to be suspended from EU market

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