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News & Press: Regulatory Updates

PHSS October 2018 Monthly Regulatory Update; Portugal benefit EU-US mutual recognition; biosimilars

16 October 2018  
Posted by: Tamsin Marshall
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PHSS Regulatory Update October 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 EU and USA regulatory authorities.


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



  • Portugal to also benefit from EU-US mutual recognition agreement for inspections
  • Improving understanding of biosimilars in the EU
  • How medicines, medical devices and clinical trials would be regulated if there's no Brexit deal
  • Submitting regulatory information on medical products if there's no Brexit deal
  • Batch testing medicines if there's no Brexit deal


  • Opioid analgesic risk evaluation and mitigation strategy (REMS)

  • Product identifier requirements under the drug supply chain security act (DSCSA)

  • Adverse Event reporting for outsourcing facilities under section 503B of the FD&C Ac

  • Heparin-containing medical devices and combination products  : recommendations for labelling and safety testing

  • Good Review Management Principles and Practices for new drug applications and biologics license applications

  • ANDA submissions — content and format

  • Guidance Documents CBER is planning to publish during calendar year 2018 

  • Drug shortages Task Force



  • USFDA updates recall lists and releases method for the detection and quantification of NDMA in valsartan.
  • Valsartan:EMA review of impurities extended to other sartan medicines.

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