MHRA Regulatory Flexibilities during the COVID-19 Pandemic

In the wake of the on-going fallout from the COVID-19 pandemic, the MHRA has been active in taking steps to lessen the regulatory burden on companies working on issues central to the fight against COVID-19.

Since the first publication of the guidance on the 1st April 2020, the MHRA have been working to continually update the information as further flexibilities are introduced. As it stands the MHRA have adjusted their practices to provide flexibilities in the following areas:

  • The management of clinical trials during the pandemic
  • Scientific advice timelines for possible COVID-19 treatments
  • QP declarations (in the absence of on-site audits)
  • Variation timelines
  • Possibilities for over-labelling
  • Relaxation of pharmacovigilance measures
  • GMP/GDP/GxP practices
  • Desk-based inspections
  • Hospital blood banks
  • Streamlined approaches and prioritisation for medical devices that are of use in the fight against COVID-19 (critical care devices, COVID-19 testing devices and PPE)

It is worth noting that the latest update from the MHRA was to reiterate that these flexibilities are temporary and any medicinal product which benefits from these regulatory flexibilities still remains subject to the conditions of its marketing authorisation.

As the guidance is being continuously updated, we at JensonR+ will be continuing to monitor the situation, so follow us on LinkedIn to receive any updates. If you would like to discuss the potential impact of this change to your business, then please do not hesitate to contact us at consultancy@jensongroup.com.

Ben Smith