Welcome Dilyana
We are delighted to welcome Dilyana to the Fusion Pharma team as our newest Regulatory Affairs Consultant. Dilyana joins us with extensive experience gained across both the MHRA and the pharmaceutical industry, bringing valuable insight into the regulatory challenges involved in developing and licensing medicines. Her expertise and collaborative approach make her a fantastic addition […]
National vs IRP – what are the pros & cons
Part of a successful regulatory strategy is to assess all available routes to licensing medicines and select the most appropriate option by carefully weighing the pros and cons of each. Since Brexit, the regulatory landscape continues to evolve and one of the most popular post-Brexit routes is still the International Recognition Procedure (IRP), which […]
ePIL updates in the UK and EU
ePIL plans are progressing in both the UK and the EU. The aim is to make medicines information easier to access and easier to use, while also helping to reduce paper waste. But the message from regulators is still clear: paper leaflets are not going away any time soon. For now, digital information is being […]
Ex-regulator tips for streamlining your dossier
I still vividly remember my days at the MHRA – reviewing countless dossiers, applications, and cover letters under tight timelines. Sifting through complex justifications, tables, and supporting data to reach a final decision was not always easy. Each application was scrutinised to ensure that public health was protected, while also enabling Marketing Authorisation Holders (MAHs) […]
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 […]
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 […]
Fusion Day (and Night)
Earlier this month, the Fusion team stepped away from our desks for one of our regular Fusion Days, which take place several times a year. These moments are an important part of how we work, giving the team dedicated time to come together, reflect and plan with intention. This latest session was hosted once again […]
Clinical Trials Regulations – What you need to know
New Clinical Trials Regulations Guidelines The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 represent the most significant overhaul of UK clinical trials regulation in two decades. Signed into law on 11 April 2025, these regulations take full effect from 28 April 2026, following a 12-month implementation period designed to help sponsors prepare for […]
Artificial Intelligence in Regulatory Affairs
A tool we use to assist, not a substitute for expertise Artificial intelligence is becoming part of everyday working life across regulated industries. At Fusion Pharma, we actively engage with AI as part of our toolkit, but always with a clear understanding of its benefits, limitations, and risks. Where AI adds value We use […]