Last weeks round-up; 6 -10 April 2020
MHRA COVID-19 – REGULATORY FLEXIBILITIES
MHRA published ‘Collection MHRA guidance on coronavirus (COVID-19)’ on the 19th March 2020 providing guidance to industry during the COVID-19 pandemic, this document is continually under review and is updated as required. One specific area covered within guidance is Regulatory Flexibilities, MHRA is meeting weekly to address implications of COVID 19 pandemic as they arise for medicines and medical device sectors. MHRA has already published a number of GDP and GMP flexibilities and continues to add additional flexibilities as and when needed. Keep up to date on all COVID-19 regulatory flexibilities by checking the published guidance collection linked here https://bit.ly/39HWh1P on the MHRA website.
NICE: GET JOINT SCIENTIFIC WITH MHRA AND NICE – CASE STUDY
The UKs NICE has posted feedback on a joint Scientific Advice process conducted with MHRA and a team from the University of Birmingham. The applicant was trying to establish what evidence would be needed in order to licence the product and ensure future reimbursement of the product. Full details of their experience is detailed under this link https://lnkd.in/dABayiQ