On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19. The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as office-based assessments and information-exchange with its international regulatory network.
‘Essential’ on-site inspections
GxP inspections ensure that UK and relevant overseas sites, engaged in laboratory studies, clinical trials, manufacturing, distribution, and pharmacovigilance, comply with MHRA standards of safety monitoring, product quality and accountability, amongst others.
The Agency is balancing the UK Government’s advice to limit on-site inspections to prevent the transmission of COVID-19 with the importance of ensuring compliance with MHRA standards. The MHRA clarified that it will continue to prioritise essential clinical trial authorisation applications. Also, for the foreseeable future, ‘essential’ on-site GxP inspections are:
(i) sites linked to the UK Government’s COVID-19 response; and
(ii) sites that pose a potential serious public health risk and cannot be assessed remotely.
On-site inspections, where necessary, will continue to operate as normal. This includes potential unannounced visits. During on-site inspections, MHRA inspectors will strictly follow all UK government public health measures to prevent the spread of COVID-19.
Remote protection of public health
The MHRA aims to monitor organisations’ compliance through its remote assessment procedures and communications with its international regulatory network. For example:
- Office-based inspections. The MHRA will request inspected organisations to provide electronic copies of documents and other information for review off-site. Any follow-up will be conducted via email and teleconferences. Where necessary, an on-site inspection will be scheduled when travel restrictions are lifted.
- Pharmaceutical Inspection Cooperation Scheme (“PIC/S”). PIC/S is a confidentiality arrangement between 53 global inspectorates, mutual recognition partners and other regulators. The MHRA will rely on inspection information shared by the network to monitor international organisations and their supply chains’ compliance.
Notwithstanding the reduction in inspectorate on-site presence, the Agency expects organisations to maintain GxP compliance and be prepared to take “flexible and pragmatic approaches” to ensure the protection of public health. For organisations awaiting licences that usually require an on-site GxP inspection, it is not clear whether the MHRA will issue licences without an on-site inspection or if considerable delays should now be expected. As the situation evolves, the MHRA will continue to update organisations and their supply chains on its proposed approach.