MHRA release guidance on the decentralised and mutual recognition reliance procedure for marketing authorisations

Following the end of the transition period, the Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to obtain a marketing authorisation (MA) in the United Kingdom (UK) or Great Britain (GB) using the decentralised and mutual recognition reliance procedure (MRDCRP). Read more “MHRA release guidance on the decentralised and mutual recognition reliance procedure for marketing authorisations”

The latest MHRA guidance surrounding clinical trials and Brexit

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released their latest guidance on conducting clinical trials for investigational medicinal products (IMP) after the transition period. It sets out requirements for the registration, publication of summary results and amendments to clinical trials, as well as submitting clinical trial safety reports. Read more “The latest MHRA guidance surrounding clinical trials and Brexit”

MHRA reveal new Brexit guidance on QPPV and PSMF requirements

As of 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) have published new guidance on the qualified person responsible for pharmacovigilance (QPPV) and the pharmacovigilance system master files (PSMF) for existing marketing authorisation holders (MAH) in the United Kingdom (UK) in light of Brexit. Read more “MHRA reveal new Brexit guidance on QPPV and PSMF requirements”