This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Print Page   |   Contact Us   |   Sign In   |   Register
News & Press: Regulatory Updates

PHSS Regulatory Update July 2020: EMA and FDA agree new priorities; Multivariate Statistical Process

01 July 2020  
Posted by: Tamsin Marshall
Share |

PHSS Regulatory Update July 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, China, ICMRA UK, PIC/s, and USA regulatory authorities.

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


European Union

  • European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
  • Exchange of non public information on Health / Medical Products with Health Canada
  • Adoption of a new European Pharmacopoeia (PhEur) general chapter on Multivariate Statistical Process Control
  • The new approach to extraneous agent testing in immunological veterinary medicinal products (IVMPs) in the European Pharmacopoeia
  • COVID-19: What's new
  • EU actions to support availability of medicines during COVID-19 pandemic – update #7
  • Mandate of the European Innovation Network
  • European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines
  • Academia developing medicines for rare diseases to receive free EMA scientific advice




  • MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'



  • GMP considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing
  • Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
  • Risk Evaluation and Mitigation Strategies: Modifications and Revisions


Therapeutic Goods Administration (TGA) 

  • COVID-19 delays to adoption of TGO 91 labels
  • COVID-19 and eligibility to request consent to supply therapeutic goods that do not comply with the new labelling requirements of TGO 92
  • Notice - the implications of adopting the PIC/S Guide to GMP PE009-14
  • Country of origin and medicine quality


  • Newly Revised Provisions for the Supervision and Administration of Drug Production

International Coalition of Medicines Regulatory Authorities (ICMRA)

  • Supporting the development of COVID-19 vaccines and treatments


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


  • The value of safe and effective vaccines
  • Levothyroxine product - specific bioequivalence guidance (EU)


  • From laboratory to patient: the journey of a medicine assessed by EMA

Membership Software Powered by YourMembership  ::  Legal