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  • Clinical trials of medicines - Annual report 2016

    | 13 June 2017 |

    Last year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.

  • Annual report on clinical trials of medicines in 2017

    | 12 June 2018 |

    The number of applications for clinical trials of medicines increased in 2017 compared to 2016, so shows the recently published annual report on clinical trials in Denmark in 2017. In 2017, the Danish Medicines Agency received 324 applications for clinical trials of medicines in humans, which is an impressive 13% increase compared to 2016. Denmark’s share of the total number of clinical trial applications in the EU has also increased steadily – from 9% in 2015 and 10% in 2016 to 12% in 2017, even though the period recorded a fall in the total number of trials in the EU.

  • Annual pharmacovigilance report 2015

    | 25 April 2016 |

    Openness and dialogue are keywords in the Danish Medicines Agency's work with adverse reactions. In 2015, this was to become particularly important. Since 2009, almost 2,000 girls and young women had reported suspected adverse reactions to the Gardasil® HPV vaccine, and patient organisations and the media wanted us to join the debate.

  • Clinical trials of medicines - Annual report 2015

    | 09 August 2016 |

    Last year, the Danish Medicines Agency received 329 applications for authorisation of clinical trials of medicines in humans – 45 applications more than in 2014. The figures appear from the Danish Medicines Agency’s annual report on clinical trials.

  • Our strategy 2017-2021

    | 15 December 2016 |

    The Danish Medicines Agency: Among Europe's best in class! This is the title of our strategy for 2017-2021, which emphasises our commitment to both public health and growth in Denmark.

  • Annual report 2013 clinical trials of medicines in humans

    | 03 July 2014 |

    The Danish Health Authority's has published its annual report 2013 on clinical trials of medicines in humans.

  • Annual pharmacovigilance report 2013

    | 30 June 2014 |

    In 2013, the Danish Health Authority, DHMA, received the highest number of adverse reactions ever. A total of 6681 adverse reactions were reported to us, which is 35% more than the year before. The boost in reports is attributable to several aspects. A number of targeted campaigns have put increased focus on the area, but also the development and implementation of better IT services have made it easier to report adverse drug reactions (ADRs). Especially the HPV vaccine against cervical cancer got a lot of attention in 2013 and accounted for a large proportion of the ADR reports.

  • Annual report 2014 - Clinical trials of medicines

    | 06 July 2015 |

    In 2014, DHMA received 284 applications for authorisation of clinical trials of medicines in humans, which is a decline of 3% on 2013. Commercial sponsors applied for 162 trials and researchers (non-c

  • Annual Pharmacovigilance Report 2014

    | 08 May 2015 |

    In 2014, the number of adverse drug reaction (ADR) reports in the Danish adverse reaction database came close to 100,000. The ADR reports go as far back as the late 1960s when the first national system for registration of adverse reactions was established.

  • Guide to individual case safety reporting

    | 26 June 2015 |

    We have prepared a guide to pharmaceutical companies about the exchange of individual case safety reports to and from the Danish Health Authority. The guide is in English and includes recommendation

  • Market surveillance project 2014 - Inspection of dental laboratories and analyses of fixed dental prosthetics

    | 24 July 2015 |

    The Danish Health Authority carried out 16 inspections of dental laboratories in 2014 and presents the results of the project in this market surveillance report. The purpose of the project was to ex

  • Adverse drug reaction reports (ADRs) from consumers may improve patient safety

    | 20 March 2013 |

    In a report, the DHMA has reviewed the ADR reports received during the years 2003–2011 to clarify how consumer reports differ from reports from healthcare professionals.

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