News about licensing of medicines

  • COVID-19: Regulatory guidance in connection with COVID-19 and possible impact on assessment times

    | 04 June 2020 |

    The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) – a network for the national drug regulatory authorities in the EU/EEA – have prepared common regulatory guidance for marketing authorisation holders. The guidance can be used during the COVID-19 pandemic and describes situations in which the authorities will apply flexibilities during the pandemic. (updated)