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First COVID-19 vaccine authorised in the European Union
| 01 March 2021 |
The European Commission has granted a conditional marketing authorisation for the Comirnaty vaccine for COVID-19 from BioNTech/Pfizer. The authorisation is valid throughout the European Union including Denmark.
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Data requirements in place in the EU for second-generation COVID-19 vaccines
| 26 February 2021 |
With continued mutations of SARS-CoV-2, the current COVID-19 vaccines may need to be adapted to ensure their efficacy. To ensure that second-generation vaccines can be made available as fast as possible, the European Medicines Agency has just issued guidance for manufacturers.
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Announcement of altered dispensing status for gadolinium-containing contrast agents (ATC code: V08CA)
| 22 February 2021 |
The Danish Medicines Agency hereby informs you that the dispensing status for all gadolinium-containing contrast agents, regardless of strength, pack size and indication is changed to ‘BEGR’ (only to be dispensed to hospitals) as of 5 October 2020.
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Danish Medicines Agency expands capacity for safety monitoring of COVID-19 vaccines
| 10 February 2021 |
The Danish Medicines Agency and drug regulatory authorities around the world find themselves in a massive historic task of monitoring the safety of COVID-19 vaccines. Thousands of people have already been vaccinated in Denmark, and within a short period of time, the rest of the Danish population is expected to be offered vaccination against COVID-19. To ensure intensive and close monitoring of the COVID-19 vaccines, the Danish Medicines Agency is stepping up its capacity by recruiting more employees to process reports of suspected side effects.
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Clinical trials of the future place the patient at the centre
| 20 January 2021 |
In many cases, participating in a clinical trial is a considerable burden for the trial subjects. Clinical trials often involve many hospital appointments with a lot of travel and waiting time. The people who are affected the most live far away from the hospital departments concerned, with resulting unequal access to clinical research in Denmark.
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Home-based clinical trials will be possible in the future
| 20 January 2021 |
Participate in a clinical trial from the comfort of your own home. It may sound a little crazy, but it is actually possible in many respects. The Danish Medicines Agency has started a project to enable researchers and pharmaceutical companies to conduct so-called decentralised clinical trials which by means of new technologies make it easier for people to participate in clinical trials. It makes it more convenient for the participants and increases efficiency, while ultimately getting medicines to market faster for the benefit of patients.
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EMA’s expert committee meets 6 January to decide on Moderna’s COVID-19 vaccine
| 22 December 2020 |
The expert committee of the European Medicines Agency, EMA, which is presently assessing Moderna’s application for conditional marketing authorisation of their COVID-19 vaccine in the EU has scheduled a meeting on 6 January at which it may recommend authorisation to the European Commission. If so, the European Commission may formally authorise the vaccine within a few days.
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EMA starts rolling review of corona vaccine from Janssen
| 02 December 2020 |
The European Medicines Agency, EMA, has started a rolling review of data from the clinical trials of a potential COVID-19 vaccine from the manufacturer Janssen. The EMA has previously started the same process for other potential vaccines from AstraZeneca, BioNTech/Pfizer and Moderna.
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EMA receives the first applications for conditional marketing authorisation of COVID-19 vaccines
| 02 December 2020 |
The EMA has received the first two applications from companies for conditional marketing authorisation of COVID-19 vaccines. The authorisations could be granted in only a few weeks’ time if the agency’s independent pharmaceutical experts assess the documentation on efficacy and safety to be sufficient.
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Remdesivir for treatment of COVID-19 to continue in Denmark and Europe until further notice
| 24 November 2020 |
Remdesivir for the treatment of hospitalised COVID-19 patients will continue in Denmark and the rest of Europe, awaiting the collection of further data that will provide conclusive evidence on the medicine’s efficacy and safety.
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The Danish Medicines Agency can again receive electronic adverse reaction reports via E2B
| 23 November 2020 |
Please be informed that the gateway for SUSAR submission is now available again. If You after 48 hours have submissions that are pending acknowledgements, please contact the Danish Medicines Agency.
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Fourth contract ensuring access to a potential COVID-19 vaccine
| 19 November 2020 |
Denmark has entered into a fourth contract with a vaccine manufacturer that will ensure the delivery of vaccines for COVID-19; the contract is signed by the European Commission on behalf of the EU member states. The contract means that about 2 million people can be vaccinated against coronavirus, provided the vaccine is approved by the authorities.
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EMA starts rolling review of corona vaccine from Moderna
| 17 November 2020 |
The European Medicines Agency, EMA, has started a rolling review of data from the clinical trials of a potential COVID-19 vaccine from the manufacturer Moderna. The EMA has previously started the same process for other potential vaccines from AstraZeneca and BioNTech/Pfizer.
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Opens today: New Data Analytics Center is to give people better and safer medicines and medical devices
| 16 November 2020 |
Today, the Danish Medicines Agency officially opens its new Data Analytics Center (DAC), a center that is to translate information and data about medicines and medical devices into knowledge that will benefit the general public. Objective: Better and safer medicines and medical devices.
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The Danish Medicines Agency is replacing its register of medicines
| 13 November 2020 |
The Danish Medicines Agency´s current register of medicines – called KAT – is being replaced with a new and improved register. The new register is built on a Microsoft Dynamic CRM-platform and has been named “LEOPARD”, which is an abbreviation for “The Danish Medicines Agency´s Electronic Information- Packaging and Address-register for Denmark”. LEOPARD is scheduled to be implemented on November 23, 2020.
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The Danish Medicines Agency cannot receive electronic adverse drug reactions via E2B in the period November 19th from 10:00 CET to November 24th
| 11 November 2020 |
Due to implementation of a new IT-system is it not possible for the Danish Medicines Agency to receive electronic adverse drug reactions (SUSARs) via E2B (DKMAEUDRA) in the period November 19th (10:00 CET) to November 24th 2020. Submissions to EVCTMPROD are not affected.
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Opioid use in Denmark is decreasing
| 04 November 2020 |
Total sales of opioids have decreased by more than 20 per cent in the past four years, and there are now fewer Danes who use the most common type of opioid, tramadol. So reveals two new studies from the Danish Health Data Authority and the Danish Medicines Agency.
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Extraordinary measures for clinical trials due to COVID-19
| 09 October 2020 |
UPDATED. We are aware that COVID-19 has consequences with regards to the conduct of clinical trials in Denmark. Multiple factors play a role such as trial participants in quarantine, limited access to public places (including hospitals) due to the risk of spreading infections etc.
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A rolling review of one more potential COVID-19 vaccine has started
| 06 October 2020 |
A rolling review of one more potential COVID-19 vaccine has been started by the European Medicines Agency, EMA. This happens only five days after the EMA started the same process for AstraZeneca’s potential COVID-19 vaccine.
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EMA: Transparency and scientific independence – the basis for authorising COVID-19 vaccines in the EU
| 06 October 2020 |
The European Medicines Agency, EMA, has stated in an announcement that its high standards for transparency and independence will be upheld when its experts assess and potentially authorise COVID-19 medicines and vaccines. “We need to hurry, but we must never rush things through”, said Director General of the Danish Medicines Agency, Thomas Senderovitz.
