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News & Press: Regulatory Updates

PHSS Feb 2018 Reg Update: EMA surveys Pharma; Good ANDA Submissions; MHRA exit preparations

08 February 2018   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update February 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:

 

Europe

  • EMA surveys pharma companies on their preparedness for Brexit
  • Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation
  • Is an orphan medicine still an orphan once it gets on the market?
  • Suppression of the Test for Abnormal Toxicity from the European Pharmacopoeia
  • MHRA update to pharmaceutical companies on exit preparations
  • MHRA GPvP Inspectorate Guide to MA Holder Considerations for Agreements with Pv System Service Providers
  • An Inspector Calls: Part 2, GMP Short Notice and Unannounced Inspections

USA

  • Good ANDA submission practices
  • Mixing, diluting, or repackaging biological products outside the scope of an approved Biologics License Application

 

Products

  • Human medicines: EMA highlights of 2017
  • FDA approves first treatment for breast cancer with a certain inherited genetic mutation
  • First EP monograph on a monoclonal antibody

Conference

  •  PHSS & PQG Annex 1 draft  revision insight

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