Fusion Connect
Released three times a year and delivered directly to your inbox by signing up here.
Within each issue we aim to cover current Regulatory topics as well as take the opportunity to update you on exciting developments at Fusion Pharma.
Our previous issues are included below, click on the newsletter to take you to the articles discussed:
Newsletter Issue 11 - June 2026
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
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
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,
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,
Newsletter Issue 10 - February 2026
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.
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
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
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
Newsletter Issue 9 - October 2025
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,
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
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
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
Newsletter Issue 8 - July 2025
MHRA RegulatoryConnect
In May the MHRA presented a webinar regarding the new RegulatoryConnect portal. A recording of the webinar is available on the MHRA website. The MHRA
Adding Regulatory Affairs to Employee Onboarding
The Missing Piece: Adding Regulatory Affairs to Employee Onboarding Throughout my career, I’ve made it a priority to integrate Regulatory Affairs (RA) into the onboarding
Regulatory Intelligence Insights
What is Regulatory Intelligence? Just as we use social media to stay informed about current affairs and what’s going on locally, Regulatory Intelligence (RI) keeps
NIMAR update May 2025
Recap In response to Brexit, on 1st January 2022, the UK brought in NIMAR (Northern Ireland MHRA Authorised Route) as a new supply route for
Newsletter Issue 7 - March 2025
Welcome Natasha
We’re thrilled to welcome Natasha Long to the Fusion Pharma team as a Senior Regulatory Consultant! Like many in the industry, Natasha didn’t set out
Are you too risk averse to thrive in your role?
Just to clarify, I’m not talking about life threatening risks such as swimming with sharks (I have no desire to do this!), I’m talking about
Variations Guidelines Updates
Changes to the Variations Regulation When I think about Lifecyle management, once the MAA is obtained, what springs to my mind is variations, variations, variations.
VPAG and De-branding – for Regulatory Professionals
As a regulatory professional you may be on the edge of discussions concerning VPAG, you may have heard of it but don’t really understand what
Newsletter Issue 6 - November 2024
Batch Specific Variations – are you aware of the opportunities?
Batch Specific Variations (BSVs) are one of my favourite activities to do – they are fast paced, put my regulatory expertise into action and often
How short-term mindsets can damage the long game
The consequences of short-term mindsets are of course not limited to Regulatory Affairs, they impact all matters of life such as health, finances and relationships
The new MHRA pipeline planning process
Back in August the MHRA launched their new pipeline process to allow them to better prepare for incoming work. Fusion Pharma attended the latest webinar
How the Windsor Framework will impact Pharmacovigilance
We have unpacked how the Windsor Framework (WF) affects Regulatory activities through several of our Fusion webinars and articles, so I thought it only fair
Newsletter Issue 5 - July 2024
Cost Saving in Regulatory
UK pharma companies are scrutinising their budgets more than ever before as a result of inflation, the impact of VPAS / VPAG and Brexit. With
MHRA Applications – One strike and it’s out
Earlier this year the MHRA published new guidance on established medicines, the guidance came into force on 1st March 2024. The aim of the guidance
It’s OK not to know everything in Regulatory!
Regardless of where you are in your career, you will never reach a point where you know everything. You can obviously apply this statement to
International Recognition Procedure for Medical Devices
Back in May the MHRA published a statement of policy intent, outlining the proposal of a new international recognition procedure for medical devices. This comes
Newsletter Issue 4 - April 2024
Feeling the pain of a medicine shortage – views from a patient and pharma consultant
This is a joint article, written by two of Fusion Pharma’s Senior Regulatory Consultants. The first part is written by Dr Lorraine Marsh from a
Artificial Intelligence (AI) in Pharma
Artificial Intelligence (AI) isn’t just a concept of the future – it’s a pervasive force shaping our everyday lives. From the personalized recommendations on streaming
InFusion: Membership update
In our last newsletter we introduced you to InFusion, our new membership designed to support Regulatory Affairs Departments and professionals within the UK. Over the
International Recognition Procedure (IRP)
The International Recognition Procedure (IRP) has featured in every one of our newsletters since Fusion Connect went live in 2023 – with IRP being in
Newsletter Issue 3 December 2023
A year in the life of Fusion Pharma
2023 has been an immensely successful year for Fusion Pharma, for which we are very grateful. Our clients have hugely benefited from our experienced and
InFusion Membership is Coming!
The reflection of 2023 is an excellent segue into looking at what 2024 will bring – and in a word it will be ‘InFusion’. InFusion
UK Update – International Recognition Procedure and the Windsor Framework
2023 has brought us two further ‘Brexit hangovers’… the International Recognition Procedure (IRP) and the Windsor Framework! Fusion Pharma have been closely monitoring the Medicines
Vaping – views from a Regulatory Affairs expert… and mother
Has Australia got it right? By prohibiting all varieties of vaping devices, and making them only available on prescription, Australia appears to have gone much
Newsletter Issue 2 September 2023
International Recognition Procedure
Since leaving the EU, the MHRA has had to adapt to new ways of working with less resource, leading to unprecedented delays in assessment timelines.
The Windsor Framework
The Windsor Framework was announced 8 months ago, leading to Regulatory Affairs professionals across the UK to drop their jaws in disbelief, for this meant
Fusion Footy
Did you know we sponsor an inclusive youth team on the South Coast? The Berewood Panthers Pan-Abilities Football Teams (U11s and U16s) meet on
UK joins CPTPP
Accession to the CPTPP On the 16th July 2023 the UK officially signed into the treaty confirming the UK’s accession to the Comprehensive and Progressive
Newsletter Issue 1 April 2023
Who the heck are Fusion Pharma anyway?
Who the heck are Fusion Pharma anyway? We are a wonderful bunch of Regulatory Affairs experts!! The more professional answer, however, would be… we are
MHRA new International Framework
We all know about the European Commission Decision Reliance Procedure (ECDRP) and that it has been extended to 31st December 2023. What my article will
The Windsor Framework
We can’t issue a Regulatory newsletter without referencing The Windsor Framework, can we! On 28th February 2023, the EU and the UK agreed a deal
Boosting development of children’s medicines
For as long as I can remember in my pharma career, there have always been challenges in enabling development of paediatric medicines. However, significant steps
