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News & Press: Regulatory Updates

PHSS Dec Regulatory Update: EMA Management Board update; Availability / shortages of meds; URPTG

14 January 2020  
Posted by: Tamsin Marshall
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PHSS Regulatory Update January 2020 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 Australian, EU  and USA regulatory authorities.

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

 

Europe

  • EMA Management Board: highlights of December 2019 meeting 

  • Updated Q&A on “Information on nitrosamines for marketing authorisation holders”

  • Availability / shortages of medicines

  • International collaboration on GMP inspections – manufacturers of sterile medicines.

  • Post-authorisation procedural advice for users of the centralised procedure

  • Q&A on comparability considerations for advanced therapy medicinal products (ATMP)

  • FAQ about parallel distribution

  • European Paediatric Formulary online

  • Pharmeuropa 32,1

 

International

Australia

  • Reforms to the generic medicine market authorisation process: implementation update

  • Uniform recall procedure for therapeutic goods (URPTG)

  • Medicinal cannabis manufacture

  • Export of therapeutic goods from

PIC/s

  • Draft PIC/S Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management

  • PIC/S events in Toyama, Japan, 11-15 November 2019

Products

 

  • Estradiol-containing (0.01% w/w) medicinal products for topical use
  • EMA & TGA update on metformin diabetes medicines

 


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