The Medicines and Healthcare Products Regulatory Agency (MHRA) has released information on the flexibilities it intends to use to help fight COVID-19.
MHRA has moved to speed up scientific advice and the approval process, in order to ensure products reach patients as quickly as possible. These measures are temporary, and focussed on the coronavirus pandemic.
Flexibilities are related to clinical trials, inspections, medical devices and medical regulations. MHRA says:
“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”
Read about the flexibilities in full here.