Access Consortium – Promise Pilot Pathway
Access Consortium Promise Pilot Pathway: what it is, what changed, and when to consider it When you are planning filings in more than one jurisdiction, “priority review” is one of those topics that sounds simple until you get into the detail. The Access Consortium’s Promise Pilot Pathway is worth revisiting because it aims to make […]
MHRA adopts the amended EU variation guidance
When the EMA announced the new EU Variations Regulation changes in mid-2025 (read more in the previous Fusion blogs: EU variations guidance and Type IA Annual update), the main question everyone asked was: “Would the MHRA follow and adopt the new EU variations guidance and Type IA annual reporting?” We now know that the answer […]
The new Project Revive initiative by the NHSE, Medicines UK and the MHRA
Fusion Pharma has reviewed the recent collaboration between NHS England (NHSE), the Medicines and Healthcare products Regulatory Agency (MHRA), and Medicines UK. This joint initiative aims to provide Marketing Authorisation Holders (MAHs) with the opportunity to re-evaluate inactive or “dormant” licences through the newly launched Project Revive: Rapid Reactivation Programme for Dormant Medicines Licences. What […]
How far can you push your supplement claims?
How far can you push your supplement claims before it becomes a medicine? The UK supplement industry is booming – from wellness influencers to high-street brands, everyone seems to be selling vitamins, minerals, and herbal blends promising things such as better sleep, energy, and immunity. But how far can you push those claims before you […]
MHRA Meeting Types
As part of their commitment to providing access to safe and effective medicines in the UK, the MHRA offer a variety of meeting options for Marketing Authorisation Holders and medicine developers to assist in bringing new products to the market. This blog looks at three of the most important types of meeting and how they […]
Pharma Industry Awards
We are delighted to share that Fusion Pharma has won the Communications Award at the Pharma Industry Awards UK 2025, held on 10 September at the Riverbank Park Plaza, London. Leah Heathman and Lorraine Marsh represented Fusion at the black-tie awards dinner, joining colleagues and peers from across the industry for an evening of celebration, […]
EU Pharmaceutical Legislation Reform Proposals
What is the EU pharmaceutical legislation reform? The EU has been formulating a total redrafting of its pharmaceutical legislation framework since it published its roadmap in March 2021. The general approach was agreed by the council in June 2025. This reform (or “pharma package”) aims to produce two key documents: A Regulation to incorporate and […]
MHRA Borderline Medicines Department
Understanding the MHRA Borderline Medicines Department: Protecting Public Health and Clarifying Product Classification In the complex world of consumer healthcare products, there is often a fine line between what constitutes a medicine, a cosmetic, a food supplement, or a medical device. This is where the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) Borderline Medicines […]
Updated MHRA Scientific Advice Process (+ case study)
Why might I need a Scientific Advice Meeting? Do you have any questions for the MHRA about the clinical development of your medicine, strategy for a Marketing Authorisation Application (MAA) or looking at a reclassification? Then you may benefit from a scientific advice meeting (SAM) with the MHRA. This article provides an outline of where […]
UK Generics – Variations
This blog summarises two common examples of safety variations performed on generic licences: Authority-driven safety updates (e.g. PRAC recommendations, MHRA requests), and Reference product updates. Authority-driven safety updates requiring a variation Scientific bodies such as the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products in Human use (CHMP) release new recommendations to […]