Licensing and supervision

  • 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.

  • 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.

  • 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.

  • 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 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 report on clinical trials of medicines in humans 2012

    | 25 October 2013 |

    The Danish Health Authority has published its annual report 2012 on applications for clinical trials of medicines in humans.

  • Annual Report 2012 on laboratory control activities

    | 05 August 2013 |

    The medical authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Health Authority has published an annual report for 2012 that describes our activities to the OMCL network.

  • Annual report 2011 on laboratory control activities

    | 16 May 2013 |

    The medical authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2011 that describes the activities of the Agency to the OMCL network.

  • Product defects and withdrawal of medicines 2011

    | 26 November 2012 |

    In 2011, 356 reports of medicinal product defects were registered, which is the highest number ever. The majority of the reports came from companies and other authorities and predominantly concerned defects on the package and packaging material and deviations from specifications.

  • Annual report on clinical trials of medicines in humans 2011

    | 07 June 2012 |

    The Danish Health Authority has published its annual report 2011 on applications for clinical trials of medicines in humans.

  • Product defects and withdrawal of medicines 2010

    | 12 September 2011 |

    In 2010, the Danish Medicines Agency received a total of 262 reports on product defects involving medicines. This is the highest number of reports received within the past five years.

  • Annual report 2010 of the Danish Medicines Agency's laboratory control activities

    | 22 July 2011 |

    he drug regulatory authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2010 that describes the activities of the Agency to the OMCL network.

  • Product defects and withdrawal of medicinal products in 2009

    | 15 June 2010 |

    In 2009, 186 reports of medicinal product defects were registered, which is slightly more than in 2008. Compared to 2008, the reporting sources and types of defects have shifted, and reports from the Danish Medicines Agency's own control system accounted for a larger share in 2009 compared to 2008.

  • Annual report 2009 of the Danish Medicines Agency's laboratory control activities

    | 14 June 2010 |

    The medical authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2009 that d

  • Product defects and withdrawal of medicinal products in 2008

    | 16 April 2009 |

    In 2008, 177 reports of medicinal product defects were registered, which is less than in 2007. 23 % of these reports led to products being withdrawn from the market, which is also less than in the preceding years. Most of the withdrawals effected in 2008 were occasioned by reports made by the companies.

  • Product defects and withdrawal of medicinal products in 2007

    | 19 May 2008 |

    In 2007, 202 reports about medicinal product defects were registered, which is basically on level with 2006. 28 % of these reports resulted in a withdrawal from the Danish market, which is exactly the same proportion as the year before.

  • Product defects and withdrawal of medicinal products in 2006

    | 26 July 2007 |

    In 2006 there were more reports on product defects compared with 2005. The reports concerned both marketed and non-marketed medicinal products. including magistral medicinal products which are manufactured according to a doctor's directions.

  • Product defects and withdrawal of medicinal products in 2005

    | 15 November 2006 |

    In 2005, there was almost the same number of reports on product defects as in 2004. The reports comprised both marketed and non-marketed medicinal products, including magistral medicinal products, which are manufactured according to a doctor's prescription.