MHRA and EMA roles20 Dec 2020 12:17
What does the MHRA do?
The MHRA is an executive department of the Department of Health and Social Care and is the body that regulates medicines, medical devices and blood components for transfusion in the UK.
Until the end of December, and as part of the transition period, COVID-19 vaccine candidates can be licensed via the European Medicines Agency (EMA) and that authorisation will automatically be valid in the UK.
If a suitable COVID-19 vaccine candidate – with strong supporting evidence of safety, quality and effectiveness from clinical trials – becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need.
In the event of a temporary authorisation for supply, the MHRA will evaluate the data rigorously for quality, safety and effectiveness to reach an independent, scientifically robust opinion. The data must include, for example, results from lab and clinical trials in humans, manufacturing and quality controls, product sampling, and testing of the final product.
Once the MHRA has thoroughly reviewed the data, they will seek advice from the Government’s independent advisory body, the Commission on Human Medicines. The Commission will critically assess the data too before advising the UK government on the safety, quality and effectiveness of any potential vaccine.
Any COVID-19 vaccine candidate submitted after the transition period ends in January 2021 will not need to go through a European marketing authorisation for use in Great Britain and will instead be assessed directly by the MHRA.
The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine.?It has responsibility in law to continuously evaluate all products on the UK market.
Following COVID-19 vaccine approval, the MHRA has in place a robust and proactive safety monitoring strategy which allows for near real-time safety monitoring at population level.