Posted by Claus Andersen, Partner
Administrative support for Life Sciences in the fight against COVID-19
In light of the Coronavirus outbreak the Medicines and Healthcare products Regulatory Authority (MHRA), which is the authority which supervises the Medical Device and Pharmaceutical sector, has recently released a series of guidance notes about how the MHRA will deal with certain aspects of the Life Sciences sector during the COVID-19 outbreak.
Amongst other issues the guidance notes deal with areas such as
- Regulatory flexibilities
- Clinical trials
- Inspections and good practice
- Medical devices
- Medicines and COVID-19
- News stories
One of the measures which the MHRA has put in place is, that it is prepared to apply regulatory flexibility to assist the industry in relation to development medicines and treatment of COVID-19. For example in relation to Medical Devices, the MHRA states that it will apply regulatory flexibility in the following areas
1. “Expedited advice service”, meaning that all COVID-19 enquiries are being prioritised ahead of the Agency’s standard targets.
2. “Clinical Investigations”, the MHRA will maintain a flexible and pragmatic approach to the regulatory requirements for clinical investigations such as
- 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, businesses should maintain good records of these deviations. Unless there is an impact onto patient safety, businesses do not need to notify MHRA of COVID-19 related deviations. However, all other protocol deviations must be reported to us as normal.
3. “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
4. The MHRA has issued specifications for CPAP and ventilators to ensure a continued supply of these critical medical devices during the COVID-19 crisis.
Other areas where regulatory flexibility can be applied are
a. Blood components for transfusion
b. Clinical trials
d. Medicines regulation
If you are a business and have any questions in relation to a product, where you need to deal with MHRA, please feel free to contact us
0800 923 2073 Email us