QALY is approved and will apply from 1 January 2021

Back in May 2020, the final implementation of the Danish Medicines Council's portended assessment model, QALY, was postponed to 1 January 2021, due to the COVID-19 situation. The Board of the Danish Regions has now approved the model.

Article  -  23.11.2020

The Treatment Council's method and process scopes have gone out for public consultation

The public consultation period regarding the method and process scopes of the new Treatment Council ends on 18 December 2020.  

Article  -  20.11.2020

The Danish medicines agency opens new data analytics centre

On 16 November 2020, the Danish Medicines Agency (DMA) opened a new data analytics centre (DAC). The centre will translate information and data on medicines and medical devices into knowledge that will benefit the general public and ensure better and safer medicines and medical devices.

Article  -  18.11.2020

New judgment by the Court of Justice of the European Union on access to documents in the possession of the EMA

In the appeals case C-576/19 P, the appellants' submission that access to documents should be set aside as the disclosure would be undermining the protection of court proceedings was dismissed.

Article  -  16.11.2020

Latest news on Life Science

The holidays are over - what happened on the life science law front while I was away?

Article  -  07.08.2020

New e-book about the requirements for CE-certification under the IVDR

MedTech Europe has published a new e-book about the clinical evidence requirements that must be fulfilled to obtain CE certification under the In Vitro Diagnostic Medical Regulation (2017/746) ("IVDR"). The e-book is designed to help manufacturers to better understand and comply with the requirements set out in the IVDR.

Article  -  10.06.2020

Coronavirus: new corona agency and joint European regulatory guidance for marketing authorisation holders during the COVID-19 pandemic

The Government is establishing a new corona agency to ensure the availability personal protective equipment and increased test capacity.

Article  -  18.05.2020

News from the Life Science sector - ENLI updates guides and QALY is postponed

ENLI's new guide - ENLI (the Ethical Committee for the Pharmaceutical Industry) has decided to allow the use of patients as speakers for a trial period of one year starting on 1 June 2020. Further, ENLI has updated its guides regarding financial support and pre-launch.

Article  -  15.05.2020