Notifications for the pharmaceutical industry about licensing, supervision and monitoring of medicines

  • Updated guidance on the implementation of decentralised elements in clinical trials with medicinal products

    | 10 September 2021 |

    You can now read the updated guidance on the implementation of decentralised elements in clinical trials with medicinal products - version 2.0

  • Guidance on the implementation of decentralised elements in clinical trials with medicinal products is now available

    | 04 May 2021 |

    Decentralised clinical trials with medicinal products meet the patients, wherever they are, in a faster and more efficient process benefitting both patient, healthcare professionals and industry. It is therefore gratifying to be able to announce that another important milestone has been reached in the Danish Medicines Agency's project to ensure an up-to-date and robust regulatory framework for decentralisation of clinical trials.

  • 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.

  • 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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