News Archive

MHRA - Updates to Innovative Licensing and Access Pathway (ILAP) Guidance

1st April 2025

Updates have been made to these pages.

Read More+

MHRA - March 2025 Newsletter

28th March 2025

The essential industry newsletter where we update you on our most recent activities

Read More+

MHRA - Performance Data

28th March 2025

Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function.

Read More+

EMA - Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028

26th March 2025

EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS).

Read More+

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

26th March 2025

11-13 March 2025

Read More+

EMA - interim report on the scientific advice pilot for high-risk medical devices.

26th March 2025

Added 24th March 2025

Read More+

FDA - FDA Roundup 21st March 2025

26th March 2025

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

Read More+

ICH - The eCTD v4.0 Q&A v1.9 reaches Step 4 of the ICH process

26th March 2025

Announced 20th March 2025 The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025. The eCTDv4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group on the eCTDv4.0 Implementation Package, and further to receiving new Change Requests, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.9. The eCTDv4.0 Q&A v1.9 is available for download on the ICH ESTRI page for eCTD v4.0 here.

Read More+

MHRA - MHRA launches new monthly safety bulletin

26th March 2025

Sign up today

Read More+

MHRA - Safety communications concerning medicines, medical devices and other healthcare products

26th March 2025

New Guidance

Read More+