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News & Press: Regulatory Updates

PHSS June 2020 Regulatory Update:EU COVID-19: What's new; MHRA GDP process changes

10 June 2020  
Posted by: Tamsin Marshall
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PHSS Regulatory Update June 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, Chinese, EU, UK and PIC/s regulatory authorities.

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


European Union

  • COVID-19: What's new
  • EU actions to support availability of medicines during COVID-19 pandemic – update #5
  • Decision on fee reductions (GMP) on-site inspections due to COVID-19 pandemic
  • Q&A- regulatory expectations for medicinal products for human use during the COVID-19 Pandemic (rev 1)
  • Deadline postponed for the second targeted consultation on Annex 1
  • Post-authorisation measures: Q&A
  • Risk management plan (RMP): Q&A
  • Transfer of marketing authorisation: Q&A
  • Renewal and annual re-assessment of marketing authorisation
  • Checklist for Initial Notifications for Parallel Distribution
  • Minutes of the 107th meeting of the EMA Management Board



  • How to manage temporary GDP process changes and risks through the COVID-19 pandemic



  • General considerations for pre-IND meeting requests for COVID-19 related drugs and biological products
  • Recommendations for the permitted daily exposures for three solvents—2-methyltetrahydrofuran,cyclopentyl methyl ether, and tert-butyl alcohol—according to the maintenance procedures for the guidance Q3C (R8)impurities:residual solvents

  • Orange Book Q&A Guidance for Industry (draft)


Therapeutic Goods Administration (TGA) 

  • Update to Manufacturing Principles for medicines, APIs & sunscreens
  • Reuse of face masks and gowns during the COVID-19 pandemic

  • National Medical Products Newsletter 2020 Volume 3


  • Adoption and Entry into Force of New PIC/S Guidance Documents (PI 052-1 and PI 053-1)


  • New vaccine for prevention of Ebola virus disease recommended for approval in the EU

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