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

06 April 2020  
Posted by: Tamsin Marshall
Share |

 
  • 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
International
USA
 
  • 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)
Australia
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 

Products

  • Kromeya - Withdrawal of the marketing authorisation in the EU 

Membership Software Powered by YourMembership  ::  Legal