News about Licensing and supervision

  • Good progress in Denmark-China collaboration

    | 01 July 2019 |

    The Danish Medicines Agency’s collaboration with the Chinese drug regulatory authorities has entered a new phase, reaching agreement on specific collaboration projects among which a project on quality control of radiopharmaceuticals.

  • End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency

    | 29 March 2019 |

    The Danish Medicines Agency invites pharmaceutical companies, researchers and other interested parties to an end of day meeting on the new European recommendations on complex clinical trials which aim to support the development of personalised medicine.

  • Public consultation on electronic package leaflets and summaries of product characteristics across the EU

    | 12 March 2019 |

    What should the package leaflets and labels of medicines for citizens and the summaries of product characteristics for healthcare professionals look like in the future? A public consultation on key principles about this has been launched throughout the EU, with comments to be submitted by 31 July.

  • Common European recommendations establish a framework for testing medicines of the future

    | 08 March 2019 |

    The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.

  • New EU report on big data paves the way for action

    | 01 March 2019 |

    A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.

  • New data analysis centre to open at the Danish Medicines Agency

    | 08 February 2019 |

    The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.

  • Updating of summaries of product characteristics due to changed ATC codes for 2019

    | 18 January 2019 |

    Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2019.

  • New format requirements for Marketing Authorization submissions from 1 January 2019

    | 17 December 2018 |

    The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

  • Til lægemiddelvirksomheder: Indsend variationer inden Brexit

    | 19 November 2018 |

    Storbritannien betragtes som udgangspunkt som et 3. land (udenfor EU/EEA) efter Brexit den 29. marts 2019. Lægemiddelstyrelsen opfordrer derfor lægemiddelvirksomheder til at indsende variationer snarest muligt.

  • Theme event on big data and medicine

    | 08 November 2018 |

    The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

  • Brexit: Two-year implementation period for name and address changes

    | 17 October 2018 |

    During an implementation period of maximum two years, it will be permitted to sell released packs on which a UK marketing authorisation holder or a representative is indicted as well as packs on which an EEA marketing authorisation holder or a representative is indicated for the concerned D.Sp.No. (Danish speciality number).

  • Medicines of the future in focus at World Economic Forum

    | 20 September 2018 |

    Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.

  • Danish Medicines Agency aces European benchmark survey

    | 19 September 2018 |

    The Danish Medicines Agency has just scored 4.5 of a possible 5 in the common-European survey known as the Benchmarking of European Medicines Agencies (BEMA). ”It's a really good result that will benefit all of us and may help raise the standard throughout Europe,” said the Danish health minister.

  • Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

    | 13 September 2018 |

    A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

  • Safer prescription of blood thinning agents

    | 04 September 2018 |

    A collaboration between pharmaceutical companies, pharmacies and authorities has eliminated a common cause of dosing errors involving blood thinning agents.

  • Danish Medicines Agency launches new concept for National Scientific Advice

    | 31 August 2018 |

    Today, 31 August 2018, the Danish Medicines Agency is launching a new concept for National Scientific Advice for companies, hospitals and others who request advice on the requirements applicable to clinical investigation and marketing authorisations.

  • Recall of valsartan blood pressure medicine

    | 10 August 2018 |

    Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible in order to to be switched to another type of medicine.

  • Phase I clinical trials and non-commercial clinical trials now exempt from fees

    | 11 July 2018 |

    Fees are no longer charged for Phase I clinical trials and non-commercial clinical trials of medicines. This is the result of the Growth Plan for Life Science and the Budget for 2018. The new rules entered into force on 1 July 2018.

  • Better conditions for clinical trials in Denmark

    | 03 May 2018 |

    The Danish government, the Danish People's Party and the Danish Social-Liberal Party have agreed to exempt commercial sponsors from all fees for phase I clinical trials of medicines. The government has previously decided – in connection with the Budget Bill 2018 – to remove the Danish Medicines Agency’s fees for non-commercial (research-initiated) clinical trials of medicines.

  • DKMA Update March 2018

    | 28 March 2018 |

    In this issue of DKMA Update you can read about evidence; changes to Tramadol’s summary of product characteristics; inspections of the sale of OTC medicines outside pharmacies and much more

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