# Advice for developers of COVID-19 vaccines

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/10d9c428-8693-440a-a046-82ab1510dfe7
Type: Detailed Guide
Published: November 23, 2020

> The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting developers of COVID-19 vaccines to engage in early consultations to refine their regulatory strategies and submission plans within the UK framework. This guidance emphasizes a collaborative approach, where the MHRA provides expert scientific advice and supports rolling reviews of clinical, non-clinical, and quality data. Additionally, the agency offers guidance on Good Manufacturing Practice (GMP) and the creation of comprehensive risk management plans. While the MHRA prioritizes COVID-19 vaccine applications to ensure timely assessment, it maintains the same high standards for safety, quality, and efficacy required for all medical products. As this document is a general guidance notice rather than an inspection report, there are no specific company violations or inspection dates recorded. Instead, the focus is on proactive compliance and the discussion of batch release testing. To facilitate these developments, sponsors and researchers are directed to contact the MHRA Innovation Office via their official enquiry form or email to initiate the regulatory filing process and receive tailored expert feedback.

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## Content

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 .