News Archive

EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

13th November 2023

6-9 November 2023

Read More+

EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)

13th November 2023

7-9 November 2023

Read More+

FDA - Benefit-Risk Assessment for New Drug and Biological Products

13th November 2023

The FDA has published its final guidance on Benefit-Risk Assessment (BRA), which clarifies how these considerations factor into FDA's regulatory decisions.

Read More+

ICH - Assembly Meeting, Prague, Czech Republic, October/November 2023

13th November 2023

The Assembly of the International Council for Harmonisation (ICH) met in-person on 31 October & 1 November 2023, in Prague, Czech Republic in parallel of meetings of 16 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.

Read More+

MHRA Blog - The role of genetics in medicine safety

13th November 2023

Dr Alison Cave, Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) highlights how genetics could play an important role in minimising the risk of adverse drug reactions (ADRs), and how the MHRA are working with partners across the system to make this a reality with their new Yellow Card biobank.

Read More+

FDA - Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities

25th October 2023

Today, FDA issued a draft guidance to inform industry about the agency’s continued use of remote interactive evaluations as an approach for evaluating drug facilities, as appropriate.

Read More+

MHRA and international partners publish five guiding principles for machine learning-enabled medical devices

24th October 2023

The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling reallocation of resources to improve product performance for patients.

Read More+