Virtual audits for the certification of medical devices to be allowed temporarily
The European Commission has issued a statement opening up for virtual audits for the certification of medical devices on an extraordinary basis and subject to individual assessments.
Article - 13.01.2021
5 recent decisions from ENLI about violations of the Promotion Code
The Ethical Committee for the Pharmaceutical Industry (ENLI) has just published a series of cases in which ENLI’s Promotion Code was found to have been violated.
Article - 05.01.2021
New decision from the Court of Justice of the European Union and publication of report on the assessment of the medicinal cannabis pilot programme.
Article - 09.12.2020
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