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”
Category: Regulation
Regulatory news and updates
Detailed guidance on the electronic submission process for applications to the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has detailed the registration process for submitting applications and reports through national portals. Read more “Detailed guidance on the electronic submission process for applications to the UK”
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”
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”
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”
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”
EU Regulators publish joint network strategy for the next five years
The European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) have adopted their joint network strategy to 2025. Read more “EU Regulators publish joint network strategy for the next five years”
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”
WHO draft revised guidance on GMP for investigational products
The World Health Organisation (WHO) has released a draft working document to the industry for public consultation on good manufacturing practices (GMP) for investigational medicinal products (IMP). Read more “WHO draft revised guidance on GMP for investigational products”