A Continuous Positive Airway Pressure (CPAP) device, which can help to keep coronavirus patients out of intensive care, has been created in under a week, and gained rapid approval by the Medicines and Healthcare products Regulatory Agency (MHRA). Read more “CPAP device gains rapid MHRA approval for use in COVID-19”
Category: MHRA
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency
Further information on how to manage clinical trials during the pandemic
The Medicines and Healthcare products Regulatory Agency (MHRA) have now released guidance on how investigators and sponsors should manage clinical trials during COVID-19. Read more “Further information on how to manage clinical trials during the pandemic”
How will coronavirus affect the management of clinical trials in the UK?
The Medicines and Healthcare Regulatory Agency (MHRA) have offered advice on the management of clinical trials during the coronavirus outbreak in the UK. Read more “How will coronavirus affect the management of clinical trials in the UK?”
Exciting milestone for the MHRA’s CWoW Pilot
The Medicines and Healthcare products Regulatory Agency (MHRA) announced that 100 clinical trial applications have now been authorised via their Combined Ways of Working (CWoW) pilot scheme. Read more “Exciting milestone for the MHRA’s CWoW Pilot”
MHRA demonstrate flexibility in national application procedure with quick vaccine approval
A high dose Trivalent Influenza Vaccine was granted a UK licence within seven months, compared to the standard twelve month review time for national approvals. Read more “MHRA demonstrate flexibility in national application procedure with quick vaccine approval”
Improving patient safety through integrated Yellow Card reporting
93% of GP practices in the UK will now be able to use their clinical IT system for integrated Yellow Card reporting of suspected adverse drug reactions (ADR) to the Medicines and Healthcare products Regulatory Agency (MHRA). Read more “Improving patient safety through integrated Yellow Card reporting”
Did you know the MHRA have published a new guidance on submission of nitrosamine risk evaluations?
UK Marketing Authorisation Holders (MAH) should be reviewing their manufacturing processes to identify and diminish any risk of the presence of nitrosamine impurities in their medicines. Read more “Did you know the MHRA have published a new guidance on submission of nitrosamine risk evaluations?”
MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit
In the event of a no-deal Brexit, reference medicinal products (RMP) for new generic medicines or abridged marketing authorisation applications will be required to comply with the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs). Comparator products (CP) used in these applications will need to be representative of the RMP. Read more “MHRA publishes guidance on comparator products to be used in bioequivalence and therapeutic equivalence studies, in the event of a no-deal Brexit”