#mhra

Windsor Framework returns NI medicines control to UK

The recently announced Windsor Framework seeks to restore Northern Ireland’s position as part of the UK and thereby undo the political, economic and societal challenges brought about by two years under the Northern Ireland Protocol. As over 1,700 pages of EU law will no longer apply in the region, what will be the situation for medicines supply once the deal goes through, and how will greater cooperation with the EU impact research and innovation under Horizon Europe?

20 Mar 2023

Breakfast briefing takeaways: Quality Systems in Pharma – Who, What, When?

In our latest online breakfast briefing, PharmaMedic Consultancy’s Managing Director Malcolm Barratt-Johnson, welcomed Indira Walker of Iolite Pharma Consulting, to discuss the requirements for maintaining quality across the medicine development and manufacturing process, and the important role of the Qualified Person at every stage. Read on to discover the key points that should be considered to ensure success throughout the product life cycle – and how the QP is an integral part of that journey.

27 Feb 2023

UK Government publishes response to MHRA fee consultation

The Government has published its response to the consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s (MHRA) statutory fees.

13 Feb 2023

MHRA announces new international recognition framework for MAs from 2024

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that the European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023. After that a new international recognition framework will be instituted, from 1 January 2024.

9 Feb 2023

UK leads on new regulatory framework for point-of-care medicine manufacturing

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced the establishment of a ground-breaking regulatory framework to simplify the manufacture of innovative medicines at the point of care. The UK’s Human Medicines and Clinical Trials legislation will be amended to enable this and brought to parliament later in 2023.

6 Feb 2023

MHRA ramps up assessment capacity for in-vitro diagnostic devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the designation of UL International UK Ltd as an Approved Body.

30 Jan 2023

UK MHRA updates how to report medical device vigilance

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated the way to report adverse incidents involving medical devices. Now manufacturers can submit incidents via the new MORE portal. A new registration is required.

14 Dec 2022

MHRA postpones implementation of Medical Device Regulations

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a 12-month extension to its substantial reform of the Medical Device Regulations, which will now come into force by July 2024.

14 Nov 2022

MHRA fast-tracks pill to prevent pre-eclampsia

Scientists at MirZyme Therapeutics believe they have developed a drug that, when given to women from 20 weeks of pregnancy, could stop them developing the condition.

9 Nov 2022

MHRA and NICE get Wellcome funding for regulation of mental health products

Wellcome has awarded £1.8m to the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) so that they can investigate and produce guidance on regulation of digital mental health tools.

7 Nov 2022