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News Archive
MHRA Seeks Feedback on Health Institution Exemption Policy
12th August 2025The MHRA is consulting on the health institution exemption to enhance patient access to innovative medical devices.
FDA - FDA Launches PreCheck Program to Strengthen Domestic Drug Manufacturing
11th August 2025The FDA has introduced the PreCheck programme to enhance domestic pharmaceutical manufacturing.
FDA - Warning Letter
11th August 2025Glenmark Pharmaceuticals (India)
MHRA - MHRA Designated as WHO-Listed Authority: A Milestone for UK Life Sciences and Global Health
11th August 2025The MHRA's new status as a WHO-Listed Authority enhances the UK's global health leadership.
MHRA - Patients to Receive Medicines 3–6 Months Sooner Under 10-Year Health Plan
11th August 2025Press release
MHRA Blog - FDA Warning Letters
11th August 2025Actions for licence holders following the issuing of USFDA Warning Letters.
MHRA Blog - Summer 2025
11th August 2025Summer 2025: Updates on Regulatory Reform and Innovation
EMA - Clinical Trials Highlights July 2025
23rd July 2025Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU
MHRA - Medicines and Medical Devices Act 2021 – Stakeholder survey - Open Call for Evidence
23rd July 2025MHRA invites feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021. This call for evidence closes at 11:59pm on 19 September 2025
EC - Stakeholders’ Consultation on EudraLex Volume 4
8th July 2025Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22 In light of the rapid advancement of digital technologies and the implementation of AI systems in pharmaceutical manufacturing, the update of Good Manufacturing Practice (GMP) guidelines is essential to ensure that they continue to provide clear, practical and relevant guidance for manufacturers and national competent authorities.
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