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News & Press: Regulatory Updates

PHSS Feb 2020 Regulatory Update: Avoid shortages of medicines due to Brexit; CMC info for human

07 February 2020   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update February 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 EU and USA regulatory authorities.

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

 

Europe

 

  • UK withdrawal from the EU on 31 January 2020
  • European authorities working to avoid shortages of medicines due to Brexit – updated Q&A
  • Ten recommendations to unlock the potential of big data for public health in the EU
  • Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
  • Electronic product information for human medicines in the EU:key principles
  • Court of Justice upholds EMA’s approach to transparency
  • Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
  • Q&A on impact of EU-USA MRA on marketing authorisation applications and relevant variations
  • EDQM launches new Pharmeuropa website

 

International

USA

  • CMC information for human gene therapy INDs
  • FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
  • Applications Affected by the Reorganization of the Office of New Drugs

 

Products

  • First oral GLP-1 treatment for type 2 diabetes

 

Conferences

 

  • MHRA Laboratories Practice Symposium

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