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 […]
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 goals for RegulatoryConnect are that it will provide more predictable regulatory pathways, with greater transparency and visibility for regulatory assessments to industry. What this means is that the portal access […]
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 programs of every company I’ve worked with. The basis for this passion is my belief that when the wider business understands RA’s role, our job becomes easier and fewer issues […]
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 pharmaceutical companies abreast of everything impacting their regulated landscape. It’s the systematic process of gathering, analysing, and applying regulatory information to ensure compliance and anticipate future changes. At the end […]
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 ensuring prescription only medicines (POMs) are available to Northern Ireland. Supplying medicines via NIMAR is essential on public health grounds and having this additional option for supply route means POMs […]
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 to work in Regulatory Affairs, but it turned out to be the perfect fit. With a diverse background in the field, she brings a wealth of knowledge and a hands-on […]
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 the types of risks that you will be exposed to throughout your Regulatory career. Regulatory professionals are typically diligent and compliance-orientated individuals. While these traits are valuable assets, they often […]
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. They are never ending and new challenges are always arising. Be it a change to a Marketing Authorisation Holder name, change to the packaging or change to an excipient, these […]
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 it is, or it’s possible that you’ve been told your bonus is reduced because of it. What is it and why do you need to know about it? In short, […]