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.

Researchers and vaccine manufacturers around the world are moving at full throttle to develop a vaccine against COVID-19, and in some parts of the world, drug regulatory authorities are under political pressure to authorise COVID-19 vaccines fast.

Now the European Medicines Agency, EMA, has stated in an announcement that the agency will uphold its long-standing high scientific assessment and authorisation standards in regard to medicines or vaccines for COVID-19 intended for the people in Europe, including Denmark.

“I want to make it absolutely clear. In Denmark, we leave it to our own and the other EU countries’ experts in the European Medicines Agency to assess when there is sufficient documentation to support the use of a COVID-19 vaccine or medicine in the population. We need to hurry, but we must never rush things through”, said Director General of the Danish Medicines Agency, Thomas Senderovitz.

The EMA has initiated an emergency plan one of the aims being to reduce the review times considerably so that a COVID-19 vaccine can be approved faster without compromising the strict requirements for documentation of efficacy and safety. Read more about this on the Danish Medicines Agency’s theme page about vaccines and medicines for treatment of COVID-19.

Full transparency

It also appears from the EMA’s published announcement that it will increase its normal standards of transparency. This includes for example the publication of trial data on authorised vaccines and publication of the vaccine manufacturers’ risk management plans in their entirety.

The agency will also publish more news on the development, authorisation and monitoring of vaccines, which in Denmark are disseminated by the Danish Medicines Agency.

Read the announcement from the EMA: EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines.

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