Advice for developers of COVID-19 vaccines
MHRA scientific and regulatory advice for COVID-19 vaccine developers
Sponsors and researchers developing COVID-19 vaccines are invited to contact the MHRA to discuss their regulatory strategy and plans for filing regulatory submissions in the UK.
To support companies’ development plans for COVID-19 vaccines the MHRA provides expert scientific and regulatory advice, including on rolling reviews of quality, non-clinical and clinical data, preparation of risk management plans and advice on Good Manufacturing Practice.
Applications for COVID-19 vaccines are prioritised allowing for a robust and thorough assessment to the same high standards of safety, quality and efficacy, expected of all vaccines.
Companies are also invited to discuss approaches to batch release testing.
Sponsors and researchers developing COVID-19 vaccines should contact the MHRA’s Innovation Office by filling out the enquiry form or emailing innovationoffice@mhra.gov.uk.
Further information about the MHRA’s Innovation Office.