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”
Category: MHRA
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency
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”
MHRA’s Innovative Licensing and Access Pathway initiative is now live
The Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed that as of 01 January 2021, their new Innovative Licensing and Access Pathway (ILAP) for accelerated drug development is open to applicants. Read more “MHRA’s Innovative Licensing and Access Pathway initiative is now live”
The latest on the MHRA’s involvement in Project Orbis
From 01 January 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) will join the US Food and Drug Administration’s (FDA) Project Orbis. Read more “The latest on the MHRA’s involvement in Project Orbis”
How to register with the MHRA to sell medical devices after Brexit
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance for manufacturers who intend to register to sell medical devices in the Great Britain (GB) and Northern Ireland (NI) markets after 01 January 2021. Read more “How to register with the MHRA to sell medical devices after Brexit”
MHRA update on Northern Ireland country code from 01 January 2021
In an update to their guidance on pharmacovigilance procedures post-Brexit transition, the Medicines and Healthcare products Regulatory Agency (MHRA) has added content covering country codes for Individual Case Safety Report (ICSR) submissions. Read more “MHRA update on Northern Ireland country code from 01 January 2021”
MHRA guidance on generating real-world evidence in clinical trials
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published draft guidance on randomised controlled trials (RCT) generating real-world evidence (RWE) to support regulatory decisions. Read more “MHRA guidance on generating real-world evidence in clinical trials”
What is the new UKNI marking for medical devices?
Find out more about the new UKNI marking for medical devices being placed on the Northern Ireland (NI) market. Read more “What is the new UKNI marking for medical devices?”
Catch the latest updates to the MHRA transition period guidances
The Medicines and Healthcare products Regulatory Agency (MHRA) has published further guidance and updates in relation to supplying medicines and medical devices after the end of the transition period. Read more “Catch the latest updates to the MHRA transition period guidances”