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News & Press: Regulatory Updates

PHSS April 2019 Regulatory Update: EU /USA MRA Q&A; Avoid shortages of medicines; FDA / losartan

09 April 2019  
Posted by: Tamsin Marshall
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PHSS Regulatory Update April 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 Australian, EU, PIC/s, Russian and USA regulatory authorities.

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

 

Europe

  • EU /USA MRA Q&A
  • EU authorities working to avoid shortages of medicines due to Brexit  Q&A
  • 20 years of sampling and testing programme for EU medicines
  • New EudraVigilance system improves reporting of side effects and detection of safety signals
  • EMA now operating from Amsterdam

USA

 

  • FDA not objecting to losartan with NMBA below 9.82 ppm remaining on the market
  • Nonproprietary naming of biological products: update
  • Pediatric information incorporated into human prescription drug and biological product labelling

International

Australia

  • TGA instructions for disinfectant testing
  • Risk management plans for medicines and biologicals

 

PIC/S

  • Bangladesh applies for PIC/S pre-accession

 

Russia

  • Compliance Deadline for 12 Nosologies (diseases)-Products must be Compliant by Oct 2019

Switzerland

  • Switzerland now also uses EudraGMDP

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