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
- 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 Covid19.GMDP@mhra.gov.uk on a ‘do and tell’ basis. No prospective MHRA approval is necessary
- 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.
- Expedited assessment of variations and initial applications – We are implementing priority and expedited assessment for national variations (including batch-specific variations) and initial marketing authorisation applications that impact the medicines supply chain. Guidance is in preparation on how to highlight these at the time of submission. Please send notification of requests to expedite to MHRA in advance of submission:
- Nitrosamine responses – The deadline for provision of step 1 nitrosamine responses will be extended for an additional 6 months i.e. until 1 October 2020