News

  • Substantial progress in cooperation with CFDA only six weeks after state visit

    | 23 June 2017 |

    During the official state visit at the beginning of May, the Chinese and Danish Ministers for Health and Food signed a Memorandum of Understanding about the establishment of the China-Denmark Food and Drug Regulatory Cooperation Centre. Only six weeks after the state visit, the China Food and Drug Administration (CFDA) and the Danish Medicines Agency held a successful seminar on 20 and 21 June in Beijing on the licensing of medicines and the drafting of a work programme with common activities up to and including 2020.

  • Evaluation of a Danish meta-analysis of antidepressants

    | 21 June 2017 |

    The Danish Medicines Agency has evaluated a Danish meta-analysis made by the Copenhagen Trial Unit on the effects of antidepressants (SSRIs). The analysis attracted extensive media coverage.

  • Eleven new substances on the list of euphoriant substances

    | 16 June 2017 |

    On 15 June 2017, 11 new substances were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.

  • New format requirements for marketing authorisation applications

    | 15 June 2017 |

    The Danish Medicines Agency is postponing the phasing-out of NeeS and tightens the format requirements for updating the assessment report prior to MRP/RUP.

  • Annual report 2016 - Clinical trials of medicines

    | 13 June 2017 |

    LLast 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.

  • Tramadol: It is important that we are informed of side effects

    | 13 June 2017 |

    Doctors should contact the Danish Medicines Agency if clinical experience shows that the side-effect profile of a medicinal product is not consistent with the summary of product characteristics.

  • Extensive modernisation of our IT from 8 June to 13 June

    | 08 June 2017 |

    The Danish Medicines Agency will launch an extensive modernisation of our IT systems from Thursday 8 June 2017 at 6pm to Tuesday 13 June 2017 at 8am. During this period, you may experience longer response times and some of our IT systems and forms will not be available.

  • Danish Pharmacovigilance Update, May 2017

    | 08 June 2017 |

    The May issue of Danish Pharmacovigilance Update.

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