News Archive

FDA - Roundup 12th March 2024

13th March 2024

An at-a-glance summary of news from around the agency.

Read More+

MHRA - Equity in Medical Devices

13th March 2024

The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review

Read More+

MHRA - Med Tech Regulatory Reform blog

13th March 2024

March Edition

Read More+

EMA - Launch of new HMA-EMA catalogues of real-world data sources and studies

29th February 2024

EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one for RWD studies.

Read More+

EMA - Meeting highlights from the CHMP 19-22 February 2024

29th February 2024

Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024

Read More+

EMA - Meeting highlights from the CVMP 13-14 February 2024

29th February 2024

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024

Read More+

EMA - Multi-agency report highlights importance of reducing antibiotic use

29th February 2024

Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria.

Read More+

FDA, MHRA, Health Canada Joint Symposium Videos

29th February 2024

View the streams from last week's FDA, MHRA, Health Canada Symposium

Read More+

ICH - ICH E2D(R1) draft Guideline presentation

29th February 2024

Available now on the ICH website The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.

Read More+

MHRA - Chief Executive Dame June Raine to step down later this year

29th February 2024

Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following five years in the role

Read More+