The Danish Medicines Council introduces agreed application dates and a new process for validation of applications
From 1 April 2024, pharmaceutical companies must agree on an application date with the Danish Medicines Council's secretariat when they want an assessment of a new medicinal product. At the same time, the process for the secretariat's validation of the applications will change, as the Danish Medicines Council will perform a technical validation within the first 10 working days.
Agreed application dates
Until now, pharmaceutical companies have been able to submit applications for assessments of new medicines at any time and without taking into account scheduled council and specialised committee meetings. With the new model, companies must instead, prior to an application, indicate a realistic date to the Danish Medicines Council for when they wish to submit their application, and based on the applicant's wishes and available specialised committee meetings, the secretariat of the Danish Medicines Council determines an agreed application date together with the company.
The Danish Medicines Council's introduction of agreed application dates is part of a decision by the Danish Regions to reduce the processing time for assessments of new medicines and improve the working environment. The measure is intended to ensure more efficient case handling processes and allow the Danish Medicines Council to organise the further process for the assessments. This also means that pharmaceutical companies will receive a timetable for the assessment of their medicinal product in advance, as well as a date for when the Danish Medicines Council will decide on the application.
From 1 April 2024, the Danish Medicines Council's processing time will be 14, 16 or 18 weeks, depending on the scope and complexity of the assessment.
New process for validating applications
From 1 April 2024, the Danish Medicines Council will also introduce a new process for validation of applications.
Until now, the assessment of an application's formal requirements ("technical validation") has overlapped with the actual assessment of the efficacy and side effects of the medicine.
In future, the Danish Medicines Council will perform a technical validation within 10 working days of receiving an application. In this way, the Danish Medicines Council will clarify early in the process whether the application contains the information necessary to assess the medicine.
If the application fulfils the technical validation, the Danish Medicines Council's assessment will start as planned. If the application does not fulfil all formal requirements, it will be returned to the pharmaceutical company and a new application date must be agreed upon, which will delay the assessment of the medicine.
The Danish Medicines Council will publish a technical validation checklist for pharmaceutical companies to use before submitting their application.
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