Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.

We are working closely with the Department of Health and Social Care (DHSC) and other healthcare partners and stakeholders to rapidly develop a package of ‘flexibilities’ to regulatory guidance, in order to support the medicines supply chain and wider healthcare response to the COVID-19 outbreak in the UK.

These regulatory flexibilities are:

  • temporary and will be kept under review, except where regulatory extensions have been stated
  • offered to provide flexibility in exceptional circumstances
  • effective immediately

Blood components for transfusion

We are offering temporary regulatory flexibility to hospital blood banks to help them focus on service continuity during the COVID-19 outbreak

Clinical trials

  • Expedited scientific advice, and rapid reviews of clinical trials applications to support manufacturers and researchers on potential treatments for COVID-19
  • Clinical Trials Unit/Good Clinical Practice – We have published guidance covering:
    • No need to inform the MHRA of a temporary halt of a clinical trial if related to COVID-19 and no need to inform the MHRA when it starts again
    • Guidance on posting of IMP to trial subjects, consent can be done verbally and it will not need a substantial amendment
    • Remote monitoring, allowance of remote access to medical records if appropriate security is in place
    • Reduction of subject monitoring visits will not require a substantial amendment
    • Understanding that safety reporting timelines will not always be met
    • No requirement to report an increase in protocol deviations as serious breaches


  • Routine inspections approach – we are no longer routinely undertaking onsite inspections which are being replaced with desk-based inspections in most cases
  • Specials’ licence holders – We are permitting the ‘pack down’ of large packs of licenced medicinal products into smaller quantities for retail sale by pharmacies
  • Imported products (3rd countries) – We may implement reduced re-testing where this will significantly delay Qualified Person (QP) certification and batch release (e.g. sterility tests)
  • Analytical tests for active substance identification and assay should be retained, unless manufactured in the territory of a PIC/S participating authority. The MHRA will not object to such importation re-testing being omitted where:
    • Reliance can be placed on measures such as previous testing history and full testing of each batch at the third country manufacturing site
    • A retrospective, risk-based, skip lot approach for testing imported batches is undertaken with full testing performed to inform the QP of the continued quality
    • Quality attributes that have failed import re-testing should continue to be tested unless robust preventative actions have been implemented and confirmed by the QP
    • Documentation of the justification and details of omission of tests is retained within the Pharmaceutical Quality System
    • Specialist analysis for certain biological products (e.g. vaccine inactivation tests) should continue to be performed on importation
  • QP certification – We will prioritise variations to add replacement QPs to MIA/MIA(IMP), including non-practising or retired QP. QP remote working arrangements will be permitted, where procedures facilitate this approach
  • Dedicated email address for MIA and MIA(IMP)s to notify the MHRA of use of flexibilities – MIA and MIA(IMP) holders making use of this flexibility should notify the MHRA with product name and marketing authorisation number to on a ‘do and tell’ basis. No prospective MHRA approval is necessary

Medical Devices

  • Expedited advice service; all COVID-19 enquiries are being prioritised ahead of the Agency’s standard targets.
  • Clinical Investigations: we will maintain a flexible and pragmatic approach to the regulatory requirements for clinical investigations.
    • Any amendments to existing clinical investigations as a direct result from COVID-19 will be expedited
    • Any new submissions for clinical investigations that will have a direct impact on the COVID-19 emergency will be processed through an expedited review
    • Protocol deviations as a result of COVID-19 do not need to be notified to MHRA; however you should maintain good records of these deviations. Unless there is an impact onto patient safety, you do not need to notify MHRA of COVID-19 related deviations. However, all other protocol deviations must be reported to us as normal
  • Exceptional use applications are being processed to ensure a continued supply of non-CE Marked Medical Devices where there is a significant clinical need and where there are no CE Marked Devices available
  • We have issued specifications for CPAP and ventilators to ensure a continued supply of these critical medical devices during the COVID-19 crisis.

Medicines regulation

Posted on the UK MHRA website on 2 April 2020