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