-
The Danish Medicines Agency has designated a new Danish body for certification of medical devices
The Danish company TÜV SÜD Danmark ApS has been designated as a new notified body for the certification of medical devices. The company can now begin its work to ensure that medical devices can be certified on Danish territory and placed on the market as quickly as possible for the benefit of patients, the healthcare system and the life science industry in general.
Article - 11.04.2024
-
The Treatment Council is to be closed down - tasks are transferred to a new institute
Danish Regions has decided that the Danish Treatment Council and the Danish Regions' Clinical Quality Development Programme (RKKP) will be merged into a new institute from 2025: The Danish Institute for Healthcare Quality.
Article - 11.04.2024
-
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.
Article - 20.03.2024
-
Health apps insight
Proposed framework for a new health apps board has just been published. New executive order on rules of procedure for this board is going out for consultation.
Article - 05.03.2024
-
New rules on health research and health data research projects
On 1 January 2024, an amending act on the ethical conduct of health research and health data research projects came into force.
Article - 05.02.2024
-
New ENLI guide on information material and medical devices
ENLI has prepared a new separate guide that summarises relevant information about pharmaceutical companies' access to provide information material and medical devices to healthcare professionals.
Article - 30.01.2024
-
EMA updates user guide for SMEs in the pharmaceutical sector
The European Medicines Agency (EMA) has published a revised version of its User Guide for micro, small and medium-sized enterprises (SMEs) in the pharmaceutical sector.
Article - 30.01.2024
-
Good news for sponsors of combination studies involving both drugs and IVD medical devices
A new application process and accompanying guidance will hopefully make it easier to get started with such studies.
Article - 22.01.2024