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News & Press: Regulatory Updates

PHSS July 2019 Regulatory Update: EMA activities; EU-US mutual recognition; Formal Dispute Resoln

05 July 2019  
Posted by: Tamsin Marshall
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PHSS Regulatory Update July 2019  available for download for members! Login to view


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 Australian and USA regulatory authorities.

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




  • EMA activities, other than the highest priority activities, that will continue in 2019
  • Variations to Marketing Authorisations
  • EU-US mutual recognition agreement for inspections
  • Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines
  • How to prepare and review a summary of product characteristics
  • Quality requirements for drug-device combinations
  • Q&A on the use of OOS batches of authorised cell/tissue-based ATMPs
  • MHRA The 2018 Good Distribution Practice (GDP) and GMP Symposia 




  • Formal Dispute Resolution:  sponsor appeals above the division level
  • ANDA Submissions — content and format of abbreviated new drug applications
  • Providing regulatory submissions in electronic and non-electronic format — promotional labeling and advertising materials for human prescription drugs
  • Opioid Analgesic Drugs: considerations 
  • for benefit-risk assessment framework
  • guidance for industry
  • Modernizing FDA's New Drugs Regulatory Program
  • CDER Conversation: Ensuring that standardization does not impede biological product innovation
  • FDA poliovirus assay is faster and more versatile than current assays
  • Additional safety protections regarding use of fecal microbiota for transplantation
  • Guidance Documents CBER is Planning to Publish During Calendar Year 2019
  • Bioanalytical method validation M10
  • CBER Advanced Technologies Program



  • Excluded autologous human cells and tissues
  • GMP clearance guidance update (v.18.3)




  • Premier Pharmacy Labs issues voluntary nationwide recall of all unexpired sterile drug product lots due to lack of sterility assurance

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