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News & Press: Regulatory Updates

PHSS Regulatory Update May 2015

06 May 2015   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update May 2015


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 Australia, Canada, the EU and USA regulatory authorities.

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



  • EU GMP Annex 15: Qualification and Validation
  • Conclusion of prospective pharmacopoeial harmonisation pilot project.
  • Webinar: Reverse Osmosis in Ph. Eur. Monograph for Water for Injections
  • Specification for sub-visible particles in eye drops and eye lotions
  • EU Medicines Agencies Network Strategy to 2020
  • Apply for and maintain registrations for the brokering of human medicines.
  • Mandatory use of eCTD for decentralised procedures


  • Final guidance on the evaluation and labelling of abuse-deterrent opioids
  • Critical Path Innovation Meetings Guidance for Industry
  • Environmental assessment: Q&A regarding drugs with estrogenic, androgenic, or thyroid activity - Guidance for Industry
  • Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product - Guidance for Industry
  • Scientific considerations in demonstrating biosimilarity to a reference product - Guidance for Industry
  • Biosimilars: Q&A regarding implementation of the biologics price competition and innovation act of 2009-Guidance for Industry
  • Evaluation of plastic packaging systems and their materials of construction with respect to their user safety impact.
  • CDER Ombudsman’s 2014 Annual Report



  • Consultations on adoption of European Union guidelines in Australia 
  • Evaluation of biosimilars


  • Inspections database


  • Determination that oxytocin in 5% dextrose injection products were not withdrawn from sale for reasons of safety or effectiveness

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