News

  • First COVID-19 vaccine authorised in the European Union

    | 01 March 2021 |

    The European Commission has granted a conditional marketing authorisation for the Comirnaty vaccine for COVID-19 from BioNTech/Pfizer. The authorisation is valid throughout the European Union including Denmark.

  • Data requirements in place in the EU for second-generation COVID-19 vaccines

    | 26 February 2021 |

    With continued mutations of SARS-CoV-2, the current COVID-19 vaccines may need to be adapted to ensure their efficacy. To ensure that second-generation vaccines can be made available as fast as possible, the European Medicines Agency has just issued guidance for manufacturers.

  • Announcement of altered dispensing status for gadolinium-containing contrast agents (ATC code: V08CA)

    | 22 February 2021 |

    The Danish Medicines Agency hereby informs you that the dispensing status for all gadolinium-containing contrast agents, regardless of strength, pack size and indication is changed to ‘BEGR’ (only to be dispensed to hospitals) as of 5 October 2020.

  • Danish Medicines Agency expands capacity for safety monitoring of COVID-19 vaccines

    | 10 February 2021 |

    The Danish Medicines Agency and drug regulatory authorities around the world find themselves in a massive historic task of monitoring the safety of COVID-19 vaccines. Thousands of people have already been vaccinated in Denmark, and within a short period of time, the rest of the Danish population is expected to be offered vaccination against COVID-19. To ensure intensive and close monitoring of the COVID-19 vaccines, the Danish Medicines Agency is stepping up its capacity by recruiting more employees to process reports of suspected side effects.

  • Clinical trials of the future place the patient at the centre

    | 20 January 2021 |

    In many cases, participating in a clinical trial is a considerable burden for the trial subjects. Clinical trials often involve many hospital appointments with a lot of travel and waiting time. The people who are affected the most live far away from the hospital departments concerned, with resulting unequal access to clinical research in Denmark.

  • Home-based clinical trials will be possible in the future

    | 20 January 2021 |

    Participate in a clinical trial from the comfort of your own home. It may sound a little crazy, but it is actually possible in many respects. The Danish Medicines Agency has started a project to enable researchers and pharmaceutical companies to conduct so-called decentralised clinical trials which by means of new technologies make it easier for people to participate in clinical trials. It makes it more convenient for the participants and increases efficiency, while ultimately getting medicines to market faster for the benefit of patients.

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