News about clinical trials

  • 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.

  • 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.

  • 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.

  • 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.

  • The European Commission has published three recommendations for the clinical trials regulation

    | 14 November 2017 |

    In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

  • 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.

  • New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems

    | 13 February 2017 |

    The Good Clinical Practice (GCP) inspectors of the EU member states have published a new Q&A based on the pitfalls for sponsors to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials.

  • Improved access to patient data in clinical trials for monitors and GCP inspectors

    | 05 September 2016 |

    The Danish Medicines Agency's inspectors have direct access to health information in patient records in all clinical trials on medicinal products notified from 1 July 2016.

  • More clinical trials in Denmark

    | 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.

  • Clinical trial guidelines in public consultation

    | 28 June 2016 |

    As a result of the EU's new clinical trial regulation, the European Commission has submitted four guidelines for public consultation.

  • New Danish act on clinical trials

    | 25 May 2016 |

    The Danish Parliament has adopted a new act on clinical trials of medicinal products, which means that new research ethics committees will be established. However, the act does not come into force until 2018.

  • Form for notification of invoice details concerning clinical trials discontinued

    | 23 February 2016 |

    The Danish Medicines Agency has decided to discontinue the form for notification of invoice details concerning clinical trials. Instead, the cover letter should provide details of who we should send the invoice to and any comments you want us to state on the invoice.

  • Access to results in EudraCT from 13 January

    | 13 January 2016 |

    When a clinical trial of medicinal products has ended, the trial results must be entered in the EudraCT database. The system has been unavailable for a period of time during which data could not be entered in the EudraCT database. The EMA now re-opens the database and results can be entered in EudraCT again.

  • New clinical trial regulation under way

    | 12 January 2016 |

    New EU Clinical Trial Regulation has been postponed until 2018

  • Increase in clinical trial applications

    | 03 August 2015 |

    An increasing number of clinical trial applications, improved production and assessment performance, but also longer assessment times.

  • Clinical trial authorisation applications

    | 06 July 2015 |

    In 2014, the Danish Health and Medicines Authority received 284 applications for authorisation of clinical trials of medicines in humans, which is a decline of 3% compared to 2013. Commercial sponsors applied for 162 trials and researchers for 122.

  • Consultation on transparency in clinical trials

    | 21 January 2015 |

    The European Medicines Agency (EMA) has launched a public consultation on how to implement the transparency requirements of the new EU Clinical Trials Regulation. Deadline on 18 February.

  • New rules for persons collaborating with the industry

    | 07 October 2014 |

    As of 1 November 2014, new rules governing healthcare professionals' collaboration with pharmaceutical and medical companies take effect. The rules governing association will be extended to include medical companies and nurses. Doctors' association with speciality stores trading in medical devices are also covered by the rules.

  • Good laboratory practice in non-clinical trials

    | 29 July 2014 |

    Clinical Trials Facilitation Group (CTFG) has prepared a document describing the requirements as to good laboratory practice (GLP) in non-clinical trials.

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