• Extraordinary measures for clinical trials due to COVID-19

    | 09 October 2020 |

    UPDATED. We are aware that COVID-19 has consequences with regards to the conduct of clinical trials in Denmark. Multiple factors play a role such as trial participants in quarantine, limited access to public places (including hospitals) due to the risk of spreading infections etc.

  • A rolling review of one more potential COVID-19 vaccine has started

    | 06 October 2020 |

    A rolling review of one more potential COVID-19 vaccine has been started by the European Medicines Agency, EMA. This happens only five days after the EMA started the same process for AstraZeneca’s potential COVID-19 vaccine.

  • EMA: Transparency and scientific independence – the basis for authorising COVID-19 vaccines in the EU

    | 06 October 2020 |

    The European Medicines Agency, EMA, has stated in an announcement that its high standards for transparency and independence will be upheld when its experts assess and potentially authorise COVID-19 medicines and vaccines. “We need to hurry, but we must never rush things through”, said Director General of the Danish Medicines Agency, Thomas Senderovitz.

  • Danish Medicines Agency takes tougher action to ensure the publication of clinical trial results

    | 06 October 2020 |

    A fine or imprisonment of up to four months is the ultimate punishment if the results from clinical trials of medicines are not published. The Danish Medicines Agency will be taking a tougher line on investigators – the so-called sponsors of clinical trials of medicines – if they do not publish the results of the trials they carry out.

  • EMA starts rolling review of a potential COVID-19 vaccine

    | 01 October 2020 |

    The European Medicines Agency, EMA, has started a rolling review of trial data on a potential COVID-19 vaccine. The vaccine is from AstraZeneca with which the European Commission signed a purchase contract about a month ago on behalf of Denmark (among others).