News from the Danish Medicines Agency
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Suspension of Scanpharm A/S's authorisation to manufacture medicines
| 07 November 2019 |
The Danish Medicines Agency has suspended parts of Scanpharm A/S’s authorisation to analyse medicines before these are made available to patients.
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More resources to improve the patient safety of medical devices
| 29 October 2019 |
Patient safety is to be improved by a threefold increase in staff and a restructuring of the agency’s Medical Devices Unit into four specialised teams.
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New concept for regulatory advice on medical devices
| 28 August 2019 |
The Danish Medicines Agency has launched a pilot project to offer targeted advice on rules and regulations in the area of medical advices to startups and small and medium-sized medical device manufacturers as well as educational and research units. New rules are under way throughout the EU from 2020.
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Supply of cannabis oil from Stenocare affected in Denmark
| 12 July 2019 |
Several consignments of cannabis oil from the Danish firm Stenocare have been placed in quarantine and taken off the market because the cannabis used in the oil was cultivated in non-approved facilities. The supply of cannabis oil in Denmark will therefore be affected.
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Danish Medicines Agency strengthens its policy on conflicts of interest
| 05 July 2019 |
New staff members of the Danish Medicines Agency are not permitted to own shares in pharmaceutical or medical device companies. Currently employed staff will be asked to divest any shares within two years. This appears from the agency’s internal policy on conflicts of interest, which enters into force on 4 July 2019.
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Good progress in Denmark-China collaboration
| 01 July 2019 |
The Danish Medicines Agency’s collaboration with the Chinese drug regulatory authorities has entered a new phase, reaching agreement on specific collaboration projects among which a project on quality control of radiopharmaceuticals.
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Withdrawal of vaginal mesh
| 03 May 2019 |
Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient. As a result, the products will no longer be available in Denmark.
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Report on suspected side effects reported for medicinal cannabis
| 10 April 2019 |
Dizziness, nausea and concentration problems are some of the suspected side effects that have been reported to the Danish Medicines Agency in the first year of the medicinal cannabis pilot programme.
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Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries
| 14 March 2019 |
Today, the Danish Medicines Agency signed an agreement with WHO to help build up drug regulatory authorities in low- and middle-income countries, including Africa.
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Public consultation on electronic package leaflets and summaries of product characteristics across the EU
| 12 March 2019 |
What should the package leaflets and labels of medicines for citizens and the summaries of product characteristics for healthcare professionals look like in the future? A public consultation on key principles about this has been launched throughout the EU, with comments to be submitted by 31 July.
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Vaginal mesh from Bard removed from the EU markets
| 12 March 2019 |
The company Bard has decided to stop the sale of vaginal mesh implants on the markets in the EU. The decision is based on commercial reasons according to Bard.
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New EU report on big data paves the way for action
| 01 March 2019 |
A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.
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New data analysis centre to open at the Danish Medicines Agency
| 08 February 2019 |
The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.
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DKMA Update December 2018
| 23 January 2019 |
In this issue of DKMA Update you can read about safety for medical devices; new biosimilar medicines for Humira; better conditions for clinical trials in Denmark; new front page for our website and much more
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New report on adverse reactions reported with tramadol for pain relief
| 20 December 2018 |
The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.
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Theme event on big data and medicine
| 08 November 2018 |
The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.
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Three research projects to increase our knowledge of medicinal cannabis
| 01 November 2018 |
Three projects have just been granted funds to give us more knowledge about the efficacy of medicinal cannabis. A total of DKK 5 million have been distributed of the funds that were appropriated by the negotiating parliamentary parties under the special funds agreement 2018-2021 to accumulate scientific knowledge of medicinal cannabis.
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Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide
| 30 October 2018 |
There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.
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Debate on research dissemination at the Danish Medicines Agency
| 28 September 2018 |
On 1 October, the Danish Medicines Agency and the Danish Society for Pharmacoepidemiology have invited a number of researchers, doctors and communication officers from research institutions throughout Denmark to a debate on how the findings of new health research can be disseminated most responsibly. The debate meeting can be followed live on the Danish Medicines Agency’s Facebook profile.
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Drug agency from China visits Denmark
| 28 September 2018 |
A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen regulatory efforts in the two countries.