MHRA regulatory flexibilities resulting from coronavirus (COVID-19)
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Latest change: We have identified areas of flexibility which differ from the EU. These are indicated by an asterisk (*). Please be aware that some UK flexibilities, while aligned with those of the EU, are not limited to treatments for COVID-19 products, but cover the supply of other essential products that have been affected by the outbreak by factors such as travel and transportation restrictions or shortages of starting materials. These are indicated by two asterisks (**).
AI Summary
This guidance, issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) between April 2020 and February 2021, outlines temporary regulatory flexibilities introduced to maintain the healthcare supply chain during the COVID-19 pandemic. Operating under the Human Medicines Regulations, the MHRA collaborated with the Department of Health and Social Care to provide immediate relief for manufacturers while ensuring product safety remains the priority. The guidance addresses several deviations from standard protocols. Key measures include replacing routine on-site inspections with desk-based assessments, extending re-audit windows for manufacturing sites to five years, and allowing remote Qualified Person (QP) audits. Additionally, the MHRA implemented expedited reviews for COVID-19 clinical trials and extended deadlines for nitrosamine risk evaluations and label change implementations from six to nine months. In terms of pharmacovigilance, risk minimisation measures such as pregnancy testing were permitted to occur remotely, and reporting priorities for serious safety cases were adjusted. Required actions for manufacturers and wholesalers utilizing these flexibilities include notifying the MHRA via a dedicated email address on a 'do and tell' basis. These notifications must specify the manufacturing authorization number, the specific flexibility used, and the expected duration. Companies are still obligated to ensure products are safe and must document scientific justifications for any implemented changes.
The full document, source attachments, and change history are available on KeyPedia. Sign in to view.