United States withdraws from World Health Organisation
The World Health Organisation (WHO) is an agency within the structure of the United Nations (UN), formed in 1948 to coordinate international efforts to tackle global physical, mental and social health challenges and emergencies. With the withdrawal of the United States from this structure on 22 January 2026, and Argentina confirming their intention to follow, […]
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 […]
Medicine Repurposing and Line Extensions
What is medicine repurposing? Some medicinal products have been found to have therapeutic uses outside of their licensed indication(s) and/or instructions for use. While this undoubtedly provides a benefit to patients, a legal issue remains over the off-licence use of medicines. Repurposing moves the newly discovered off-label use to be on-label, so the medicine becomes […]
Welcome Aidan!
We are delighted to welcome Aidan Roberts to the Fusion team. He has quickly settled into his new role, bringing fresh energy, a thoughtful approach, and valuable expertise to both our internal projects and client work. In just a short time, Aidan has already made a positive impact, and we are excited to see his […]
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 […]
UK Generics – How to compare your product information to a reference product
What is a reference product? A reference product is an innovator Marketing Authorisation (MA) that is periodically referred to when updating the safety information in a generic licence. The chosen reference product forms part of the basis for a generic licence to be granted by the competent authority. Which products use a reference? Many generic […]