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News & Press: Regulatory Updates

PHSS Apr 2018 Regulatory Update: MHRA OOS Guidance; Mutagenic imp in pharma carcinogenic risk

09 April 2018   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update April 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 Australian, EU & USA regulatory authorities.

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



  • EMA Management Board: March 2018 highlights
  • Rapid implementation of the PH Eur monograph Products of fermentation (1468)
  • MHRA Out of Specification Guidance
  • MHRA ‘GXP’ Data Integrity Guidance and Definitions
  • MHRA Operational Transformation Programme


  • M7(R1) Assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
  • Evaluation of bulk drug substances nominated for use in compounding under section 503b of the FD&C Act
  • Elemental Impurities in Animal Drug Products
  • Guidance on Proprietary Names for New Animal Drugs
  • Office of Pharmaceutical Quality annual report 2017



  • Australian regulatory guidelines for biologicals (ARGB)
  • Pre-submission meetings with TGA


  • Withdrawal of pain medicine flupirtine
  • Immediate suspension and recall of multiple sclerosis medicine Zinbryta

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