Horizon Scanning Assessment Report – Artificial Intelligence

EN BREF ...

" New technologies are increasingly challenging regulatory frameworks. In response to this, the International Coalition of Medicines Regulatory Authorities (ICMRA) has set up an Informal Network for Innovation. This network seeks to adapt regulatory frameworks to facilitate safe and timely access to innovative medicines. As part of this, horizon scanning is being used to identify challenging topics and develop hypothetical case studies to stress-test existing regulatory frameworks and develop recommendations to adapt them. To date, ICMRA members have identified three such topics: 3D printing,1 gene editing and artificial intelligence. This report details the results of the horizon scanning exercise in Artificial Intelligence (AI), with relevance for regulators and stakeholders across the medicines development landscape. The Informal Network for Innovation working group members in this report were the Italian Medicines Agency (AIFA), the Danish Medicines Agency (DKMA), the European Medicines Agency (EMA) as working group lead, the USA’s Food and Drug Administration (FDA) as an observer, Health Canada (HC), the Irish Health Products Regulatory Authority (HPRA), Swissmedic and the World Health Organisation (WHO)..."