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PHSS March 2018 Regulatory Update; Transposition report on Falsified Medicines; Recall Public Notice

06 March 2018   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update March 2018


During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month all reported issues have come from the EU and USA regulatory authorities.

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



  • Falsified medicines Directive – report on transposition
  • EDQM guidance for electronic submissions for CEPs applications
  • Ph.Eur revised general chapters on plasticised PVC materials
  • Revised EDQM guideline "Content of the dossier for a substance for TSE risk assessment"
  • Four more EU Member States benefit from EU-US MRA for inspections
  • Work plan for the GMP/GDP Inspectors Working Group for 2018
  • General Court confirms EMA approach to transparency
  • Evaluation of advanced therapy medicines
  • Strengthened guidance on follow-up and risk management for ATMP developers
  • Towards more ethical use of animals in medicine testing
  • UK and China sign MOU on Medicine and Device Regulation.


  • Public Warning and Notification of Recalls
  • Regulatory classification of pharmaceutical co-crystals.
  • Pharmaceutical equivalence
  • Initial exclusivities for new drugs
  • Considerations for applicants deciding when to submit elemental impurity data to FDA
  • Standardisation of data and documentation practices for product tracing
  • Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.



  • 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


  •  PHSS & PQG Annex 1 draft  revision insight


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