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 […]
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 […]
ILAP Relaunched
I first wrote about the Innovative Licensing and Access Pathway (ILAP) back in 2021 (and again in 2023) so many of you will be familiar with terms such as Innovation Passport (IP), Target Development Profile (TDP) and TDP Toolkit. Over the last few years significant experience of the pathway has shown that the process can […]
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 that we now explore how Pharmacovigilance (PV) activities will be impacted! You can revisit our webinars on the WF here. A quick reminder of the Windsor Framework measures: Implementation 1st […]
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 family impact perspective, followed by Leah Heathman’s view as a regulatory professional having been involved in many medicine shortage resolutions. The words we dread hearing when visiting the pharmacy […]
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 further than other countries in combating the uptake of vaping by children. This got me thinking: what should the purpose of vapes be from a healthcare point of view? And […]
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 Sunday mornings to train and regularly play weekend matches and tournaments against other local inclusive clubs. This group of incredible girls and boys has grown from less than a handful […]
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 (as part of the Paediatric Action Plan) have been made by European Union (EU) regulators in recent years to improve the situation, which we shall now explore. Enhancing the efficiency […]
NIMAR – A Closer Look
NIMAR – A Closer Look Following on from my original blog titled ‘An Introduction to NIMAR‘, today we shall have a look in more detail, particularly focussing on Distribution of NIMAR medicines to Northern Ireland Advertising and promotion of medicines on the NIMAR list How are these products supplied to Northern Ireland via NIMAR? GB-based […]
An Introduction to the Northern Ireland MHRA Authorised Route (NIMAR)
An introduction to the Northern Ireland MHRA Authorised Route (NIMAR) What is the background to NIMAR? Following Brexit the UK Government brought in a new supply route, NIMAR, to ensure that prescription only medicines (POMs) are available to Northern Ireland (NI). What are the criteria for going down the NIMAR route? There must be […]