News from the Danish Medicines Agency
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New campaign aimed at doctors: High-quality ADR reports make a difference
| 09 July 2021 |
The monitoring of the safety of COVID-19 vaccines over the last months has shown us just how important the reports on suspected side effects from doctors are. A new campaign to promote the quality of ADR reports submitted by doctors sets out to improve the monitoring of medicine safety even further.
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Nine million packages of illegally sold medicines and medical devices seized in Operation Pangea
| 09 June 2021 |
This year’s global Interpol action Operation Pangea focused particularly on the illegal sale of medicines and medical devices related to COVID-19. In Denmark, the Danish Medicines Agency identified and reported 46 websites engaged in illicit sale of medicines and medical devices.
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Members for the Medicinal Products Committee
| 02 June 2021 |
The Danish Medicines Agency invites interested parties to nominate members to the Medicinal Products Committee for the term of 1 October 2021 to 30 September 2025. Anyone can nominate members to the Medicinal Products Committee, and self-nomination is also possible.
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New EU rules on medical devices set to strengthen patient safety
| 26 May 2021 |
Today new EU rules on medical devices enter into force. The new rules aim to strengthen patient safety and ensure that patients can benefit from new innovative devices. Medical devices cover anything from contact lenses to state-of-the-art surgical equipment.
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Dean of Aarhus University to join the Danish Medicines Agency as new Director General
| 26 May 2021 |
The Ministry of Health has appointed Lars Bo Nielsen, Dean at Aarhus University, as Director General of the Danish Medicines Agency. Lars Bo Nielsen is a qualified doctor and has extensive leadership experience within both the health and science areas.
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Annual report of the Danish Medicines Agency: The COVID-19 pandemic had a considerable impact on our work in 2020.
| 26 April 2021 |
The year 2020 was a year like no other at the Danish Medicines Agency. Both internally and externally, the handling of COVID-19 had a decisive impact on much of our work. However, we managed to retain our European position and to carry through an important reinforcement of our IT landscape, so concludes the Danish Medicines Agency’s annual report for 2020.
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EMA: Possible link between the Johnson & Johnson vaccine and unusual symptoms
| 21 April 2021 |
There is a possible link between the Johnson & Johnson vaccine and unusual symptoms with a combination of blood clots in unusual sites, low levels of blood platelets and several cases of bleeding. A few cases have been observed in the USA. The frequency of these unusual symptoms is still being investigated.
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EMA to undertake a review of data as to the AstraZeneca vaccine’s efficacy in preventing COVID-19 disease
| 15 April 2021 |
The European Medicines Agency (EMA) is undertaking a review of vaccination data of the COVID-19 vaccine from AstraZeneca. The review will include infection rates, hospitalisations, morbidity and mortality. The EMA will also prepare a recommendation for those who have received the first dose of the vaccine.
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EMA: The AstraZeneca vaccine possibly causes rare, serious symptoms – but remains authorised for use
| 08 April 2021 |
An expert committee formed by the EMA has now concluded that it is possible that the rare cases of blood clots combined with low levels of platelets and bleeding are caused by the AstraZeneca COVID-19 vaccine. It is maintained, however, that the benefits of using the vaccine still outweigh any possible risks.
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COVID-19 Vaccine AstraZeneca: Investigations of blood clots with low numbers of platelets and bleeding continue in Denmark and in the EU
| 26 March 2021 |
The EMA is convening an expert group on 29 March to provide input to the continued investigation of blood clot cases, including the very rare cases of blood clots accompanied by low numbers of platelets in people vaccinated with COVID-19 Vaccine AstraZeneca.
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Status on the drug regulatory authorities’ investigation of blood clots after vaccination with the AstraZeneca vaccine
| 18 March 2021 |
The European Medicines Agency, EMA, and the drug regulatory authorities in Europe have reviewed reports of the rare and unusual symptoms of low levels of blood platelets, blood clots and bleeding after vaccination with the AstraZeneca’s COVID-19 vaccine. The conclusion is that the AstraZeneca vaccine is generally a safe and efficient vaccine, but that it cannot be ruled out that these symptoms may be caused by the AstraZeneca vaccine.
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Danish Medicines Agency sends out updated letter to people who have received the AstraZeneca vaccine within the last 14 days
| 15 March 2021 |
Today, the Danish Medicines Agency has sent out an updated letter to people who have received the AstraZeneca vaccine within the last 14 days. The purpose is to increase awareness on the symptoms that people should react to.
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Drug regulatory authorities are investigating reports of blood clots after AstraZeneca vaccinations
| 11 March 2021 |
The Danish Medicines Agency together with the EMA and the other drug regulatory authorities in Europe have launched an investigation of the AstraZeneca vaccine after reports of blood clots in people given the vaccine. One report concerns the death of a person in Denmark. At present, there is no evidence to conclude that there is an association between the vaccine and the blood clots.
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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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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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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.