Please note this is an extract of the original bulletin.
COVID-19 test approval: how to apply
Page summary:
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
Change made:
Updated notice on change to the application process.
Global AI challenge to investigate veterans’ cardiovascular health launched
Page summary:
A brand-new challenge for artificial intelligence and machine learning developers, to build models that can predict heart failure-related health outcomes for veterans has been launched by a collaboration between regulators and healthcare organisations in the UK and US.
Change made:
First published.
Consultation on the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) Guidelines
Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) became a full member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2022 and is consulting with UK stakeholders on the ICH E6 (R3) Good Clinical Practice (GCP) guidelines to compile feedback to ICH.
Change made:
First published.
MHRA launches public consultation on ICH Good Clinical Practice Guideline which encourages innovation in clinical trials
Page summary:
The MHRA has today launched a public consultation on the revised ICH guideline on Good Clinical Practice.
Change made:
First published.
New regulatory pathway set to support safe patient access to innovative medical technologies
Page summary:
The Innovative Devices Access Pathway (IDAP), set for launch later in 2023, will be operated by the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW) and Scottish Health Technology Group (SHTG).
Change made:
First published.
MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners
Page summary:
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners
Change made:
First published.
MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines
Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced it will be the first drug safety regulator in the world to pilot its own genetic ‘biobank’, launching 1 June 2023
Change made:
First published.
