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News & Press: Regulatory Updates

PHSS Jan 2019 Reg Update: Regulatory Science to 2025; Emerging health threats (EU); Data (GCMP)

15 January 2019   (1 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update Jan 2019 available for download for members! Login to view.

 

Here are the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month xx reported issues have come from the Australian,EU and USA regulatory authorities.

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

 

Europe

 

  • Human medicines highlights 2018
  • Regulatory Science to 2025 – launch of six-month public consultation
  • Responding to emerging health threats in the EU
  • Revised guideline to assess risk of human medicines for the environment
  • MHRA-Is it really a First in Human trial? Categorising and assessing the risks correctly
  • MHRA Pharmacovigilance Inspection Metrics April 2017 to March 2018

 

USA 

  • Data integrity and compliance with drug CGMP
  • Guidance for human drug compounding outsourcing facilities
  • Post-complete response letter meetings between FDA and ANDA applicants
  • Q&A on biosimilar development and the BPCI act
  • New and revised draft Q&As on biosimilar development


International

 

Australia

  • TGA presentations on data integrity and on common inspection deficiencies
  • Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance
  • Consultation: Remaking Therapeutic Goods Order No. 78
  • Review of the Narcotic Drugs Act 1967

 

Products

  • FDA alerts health care professionals and patients not to use drug products intended to be sterile from Promise Pharmacy

Comments...

Dave Foulkes says...
Posted 18 January 2019
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