Posted on 16 Jun 2021

Regulatory News June

  • Monitoring of medical literature and the entry of relevant information into EudraVigilance by EMA
  • EMA pharmacovigilance system manual
  • EU Individual Case Safety Report (ICSR) implementation guide
  • EMA’s news related to COVID-19 vaccines:

     o EMA’s latest updates on COVID-19 vaccines
     o EMA’s overview on vaccines currently undergoing evaluation, being authorized, and undergoing safety review in the EU
     o First COVID-19 vaccine approved for children aged 12 to 15 in EU
     o Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen and Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
     o AstraZeneca’s COVID-19 vaccine: benefits and risks in context

  • EMA’s “Human Medicines Highlights" Newsletter
  • US FDA: Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments