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News & Press: Regulatory Updates

PHSS Sept 2017 Regulatory Update : Medicine Inspections EU-US cooperation; Ireland - Safeguarding

13 September 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update September 2017


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, Japan, USA PIC/S and Indian regulatory authorities.

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



  • Strengthening EU-US cooperation in medicine inspections.
  • EMA prepares for Brexit
  • Q&A production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies
  • Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances
  • Changes (expansion) of EU / Japan MRA
  • Ireland - Safeguarding future medicines supplies post-Brexit
  • UK Position Paper - Continuity in the availability of goods for the EU and the UK
  • Annex 16 QP Certification and Batch Release – FAQ – part 2


  • Child-Resistant Packaging statements in drug product labeling
  • CMC post-approval manufacturing changes for specified biological products to be documented in annual reports
  • Expiration Dating of unit-dose repackaged solid oral dosage form drug products
  •  Identifying Trading Partners Under the Drug Supply Chain Security Act
  • Integration of FDA facility evaluation and inspection program for human drugs: a concept of operations



  • 2017 draft pharmaceutical policy


  • Pre-accession applications – Saudi Arabia & Russia

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