Publications

  • 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 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.

  • 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

  • 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

  • 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

  • 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.

  • 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 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 pharmacovigilance report 2012

    | 07 August 2013 |

    In the Danish Health Authority's (DHMA's) annual pharmacovigilance report, you can read about some of the pharmacovigilance work performed by the DHMA in 2012.

  • 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.

  • Monitor the trends in consumption of drugs for acid-related disorders

    | 27 May 2013 |

    The Danish Medicines Agency monitors the consumption of drugs for acid-related disorders (drugs for heartburn, sour eructation and ulcer) in connection with the removal of the reimbursement for a number of these drugs on 15 November 2010.

  • Monitor the trends in consumption of cardiovascular medicines

    | 27 May 2013 |

    We monitor the trends in consumption of cardiovascular medicines (blood pressure medicines) in connection with the reimbursement changes for cardiovascular medicines of 13 July 2009 and 15 November 2010.

  • 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.

  • 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.

  • Annual report human on tissues and cells 2011

    | 07 December 2012 |

    The annual report for human tissues and cells for 2011 has been prepared pursuant to the Danish Tissue Act and is based on reports submitted by tissue establishments and gynaecology clinics in Denmark in the period January to December 2011.

  • 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.

  • Danish Medicines Agency's annual pharmacovigilance report 2011

    | 01 August 2012 |

    The annual pharmacovigilance report offers an insight into some of the pharmacovigilance work performed by the Danish Medicines Agency in 2011.

  • 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.

  • Number of applications for individual reimbursement of medicines in 2011

    | 02 March 2012 |

    In 2011, the Danish Medicines Agency (now the Danish National Board of Health) reviewed approx. 103,000 applications for single reimbursement (about 7 % more than in 2010), approx. 26,000 applications for reimbursement for the chronically ill (about 30 % less than in 2010), approx. 12,000 applications for reimbursement for the terminally ill (about 3 % more than in 2010) and approx. 2,500 applications for increased reimbursement (about 12 % less than in 2010), cf. table 1.

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