News

FDA details regulatory framework for AI/ML-Based Software as a Medical Device

In April 2019, the US Food and Drug Administration (FDA) published a discussion paper and request for feedback regarding their proposed regulatory framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Following feedback from the industry, the FDA has now published a five part action plan. Read more “FDA details regulatory framework for AI/ML-Based Software as a Medical Device”

The FDA details their plans to advance regulatory science in 2021

The US Food and Drug Administration (FDA) have released a report on their Focus Areas of Regulatory Science (FARS) for 2021. This document aims to “identify and communicate priority areas where new or enhanced investments in regulatory science research capacity are essential to support FDA’s regulatory and public health mission”. Read more “The FDA details their plans to advance regulatory science in 2021”

European Commission Decision Reliance Procedure provides a new route to obtain marketing authorisations in Great Britain

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”

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”