​International collaboration

Medicines authorities throughout the world are all in close dialogue with researchers and pharmaceutical companies that want to develop medicines, including vaccines, for covid-19. This also applies to the European Medicines Agency (EMA), to which Norway is affiliated. EMA is working closely together with the World Health Organization (WHO).

EMA has established a dedicated working group (the COVID-19 EMA pandemic Task Force (COVID-ETF)), which will be responsible for the rapid coordination of resources and provision of support to various research projects within the EU. In order to get covid-19 drugs and vaccines on the market as soon as possible, EMA can fast-track the regulatory timelines for the procedures at every stage until potential approval. Although EMA is establishing accelerated procedures, sufficient evidence of satisfactory efficacy, safety and quality must still be provided.

Some of the procedures that have been fast-tracked are:

Scientific and regulatory advice

EMA is offering research scientists and companies fast and free advice concerning appropriate methods and study design. The aim is to produce robust data concerning efficacy, safety and quality.

Marketing authorisation applications

  • Rolling review:  evaluates data as it becomes available. Normally, when an application for a marketing authorisation is submitted, the data will be ready before the application is submitted. However, with this procedure, data is reviewed in cycles, on an ongoing basis. When the data accumulated is considered to be sufficient, the developer can apply to EMA for a marketing authorisation. This procedure can be used when there is a serious threat to public health, such as a pandemic.
  • Accelerated procedure: developer's application for a marketing authorisation is processed faster than usual (normally 210 days, can be reduced to less than 150 days). 
The accelerated procedures are also available for therapeutics, which already have a marketing authorisation for an indication other than covid-19, in cases where the investigator wishes to expand the existing indication.
Approvals (marketing authorisations) which are recommended by EMA are adopted by the European Commission and will also apply in Norway.

Further reading

European Medicines Agency (EMA)

Update on treatments and vaccines against covid-19 under development

Norwegian Institute of Public Health (FHI)

The amount of available research into covid-19 is increasing rapidly. The Norwegian Institute of Public Health has developed a systematic and living research map for covid-19 to help decision-makers, healthcare personnel, researchers and others navigate and utilise this research.  

Danish Medicines Agency 

The Danish Medicines Agency has an up-to-date list of ongoing trials of vaccines and medicines against covid-19:
The list shows the Danish Medicines Agency's provisional assessment of trials which, based on currently available information, are worth notice. Significant trials are marked in yellow. This means that the trials have been designed such that they potentially could provide important knowledge about the development of medicines against covid-19.

 

 

Development and testing of therapeutics for covid-19https://legemiddelverket.no/english/covid-19-and-medicines/development-of-medicines-and-vaccines-against-covid-19/medicines-against-covid-19Development and testing of therapeutics for covid-19A number of medicines are currently being tested as potential treatments of covid-19. Results from several clinical trials on some of these therapeutics are now being published, and the first marketing authorisation has been granted.2611
Development and testing of vaccines for the prevention of covid-19https://legemiddelverket.no/english/covid-19-and-medicines/development-of-medicines-and-vaccines-against-covid-19/vaccines-against-covid-19Development and testing of vaccines for the prevention of covid-19The development of vaccines against covid-19 started quickly, but is still at an early stage. It takes time to develop a vaccine. It is therefore hard to say when a vaccine can be ready for use because many uncertainties need to be addressed. 2612

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