For two years from 01 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) may rely on Marketing Authorisations (MAs) approved by the European Commission (EC) via a centralised procedure when assessing an application for a Great Britain (GB) MA. The MHRA have released guidance on applying for a GB (England, Scotland and Wales only) MA through this route. Read more “European Commission Decision Reliance Procedure provides a new route to obtain marketing authorisations in Great Britain”
Year: 2021
European Commission temporarily allows notified bodies to perform remote audits
In light of the severe disruption caused by the COVID-19 pandemic, the European Commission (EC) has taken the decision to allow notified bodies to perform remote audits of medical device and in-vitro diagnostic medical device manufacturers. Read more “European Commission temporarily allows notified bodies to perform remote audits”
EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter
The Clinical Trials Regulation (EU) 536/2014 was implemented to harmonise the process of conducting and monitoring clinical trials across the European Union (EU) whilst simultaneously improving transparency. The December 2020 CTIS highlights newsletter covers the key features and future developments in the CTIS. Read more “EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter”
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”
Canada implements new regulations to strengthen post-market surveillance and risk management of medical devices
Heath Canada is making changes to its Medical Devices Regulations with the aim of improving their ability to identify, assess and manage new risks for medical devices used in Canada. Read more “Canada implements new regulations to strengthen post-market surveillance and risk management of medical devices”
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”