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PHSS May 2018 Regulatory Update; EU template for GMP non-compliance; MHRA VHP Fragility; Liposome dr

04 May 2018   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update May 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 the Australian, EU and  USA regulatory authorities.

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



  • Public consultation concerning the EU template for GMP non-compliance statement
  • Increasing oversight of API manufacturing through international collaboration
  • EMA and the Netherlands agree on Seat Agreement
  • Redistribution of UK’s portfolio of centrally authorised products
  • 160th Session of the European Pharmacopoeia Commission
  • MHRA VHP (Vapour Hydrogen Peroxide) Fragility
  • MHRA - Urgent supply of unlicensed medicines imported out-of-hours by UK hospitals.



  • Metered Dose Inhaler and Dry Powder Inhaler Products - Quality Considerations
  • Liposome drug products
  • Advancing the science of nanotechnology in drug development
  • Q7 GMP guidance for Active Pharmaceutical Ingredients Q & A
  • Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
  • New animal drug application approval process
  • Index of legally marketed unapproved new animal drugs for minor species
  • CBER inspection data



  • Half yearly performance snapshot: July to December 2017
  • Biologicals regulatory framework proposed changes
  • Management and Communication of Medicines shortages



  • FDA alerts health care professionals to voluntary nationwide recall of all sterile products from Coastal Meds LLC, Biloxi, Mississippi
  • EU citizens to be consulted on quinolone and fluoroquinolone antibiotics



  • APIC guide for auditing registered starting material manufacturers

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