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News Archive
MHRA - Innovative Licensing and Access Pathway (ILAP)
30th January 2025Full details have been published today of the refreshed UK-wide Innovative Licensing and Access Pathway (ILAP), that will offer a clearer, more streamlined and integrated process for developers to help get transformative new medicines to patients in the National Health Service (NHS) in the shortest time possible.
ICH - E6(R3) Training Available
27th January 2025The ICH E6(R3) Introductory Training Presentation is now available on the ICH website
ICH - ICH E6(R3) - Step 5
27th January 2025ICH E6(R3) (Principles and Annex 1), has reached Step 5 and will be effective from June 2025, and adopted on the 23rd July. ICH E6 (R2) remains in effect until 11 June 2025.
EMA - CVMP Meeting highlights 14-15 Jan 2025
21st January 2025Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 January 2025
EMA - PRAC Meeting Highlights - 13-16 Jan 2025
21st January 2025Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2025
MHRA - Advertising investigations: December 2024
21st January 2025Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines - published 20th Jan 2025.
PIC/S - AUDA-NEPAD - a new PIC/S Associated Partner Organisation
21st January 2025The African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD) becomes a new PIC/S Associated Partner Organisation
WHO - United States to Withdraw
21st January 2025US intends to withdraw from WHO
EMA - ICH E6(R3) Revision Workshop and Annex 2
20th January 202519th-20th February 2025
MHRA - Medical Devices Regulation 2024
20th January 2025The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation Medical devices: periodic safety update report (PSUR)
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