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News & Press: Regulatory Updates

PHSS Regulatory Update April 2020: COVID-19; EMA to issue electronic certificates; Q3D(R1)

06 April 2020  
Posted by: Tamsin Marshall
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  • Coronavirus disease (COVID-19)
  • EMA to issue electronic certificates for medicines
  • Qualification of novel methodologies for medicine development
  • Nitrosamine impurities
  • EMA to review ranitidine medicines following detection of NDMA
  • EMA Management Board March 2020
  • Brexit-related guidance for companies
  • EMA publishes ICH guideline Q12
  • Veterinary post-authorisation Q&A
  • Update on the European Pharmacopoeia (PhEur) policy on elemental impurities – Excipients of natural origin
  • Tetanus vaccines – Rationalising toxicity testing requirements
  • Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines
  • MHRA Good Practice (GxP) inspections during the COVID19 outbreak
  • MHRA Coronavirus guidance
  • Advice for Management of Clinical trials in relation to Coronavirus
  • Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)
  • Veterinary post-authorisation Q&A
  • The “Deemed To Be a License” provision of the BPCI Act Q&A
  • Safety Testing of Drug Metabolites
  • Q3D(R1) Elemental Impurities
  • Competitive Generic Therapies
  • Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
  • Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
Therapeutic Goods Administration (TGA) 
  • Physical samples for batch release not required: a reminder for sponsors of biosimilars and biological medicines
  • TGA suspends overseas GMP inspections and QMS audits
  • TGA to expand quality audits for medicinal cannabis 


  • Kromeya - Withdrawal of the marketing authorisation in the EU 

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