News Archive

MHRA - Updated Guidance Software and artificial intelligence (AI) as a medical device

14th June 2024

This guidance provides access to important Software Group outputs that might be of assistance.

EMA - ACT EU launching two advice pilots

13th June 2024

The Accelerating Clinical Trials in the EU (ACT EU) initiative is today (10th June 2024) launching two advice pilots aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe.

Read More+

FDA - Research on AI/ML-Based Medical Devices

13th June 2024

CDRH’s Office of Science and Engineering Laboratories (OSEL) Information.

Read More+

ICH - Assembly Meeting

13th June 2024

ICH Assembly Meeting Write Up, Fukuoka, Japan, June 2024 The Assembly of the International Council for Harmonisation (ICH) met in-person on 4 & 5 June 2024, in Fukuoka, Japan in parallel of meetings of 13 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. The ICH continues to expand and welcomed ANMAT, Argentina and JFDA, Jordan as new ICH Members, bringing ICH to a total of 23 Members and 35 Observers.

Read More+

ICH E6(R3) EWG Work Plan

11th June 2024

Published Work Plan

Read More+

EMA - Annual Report 2023

6th June 2024

Published on 30th May 2024 EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive features, the report offers insights into EMA's strategic initiatives and priority areas that guided its work in 2023.

Read More+