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 […]
The new Project Revive initiative by the NHSE, Medicines UK and the MHRA
Fusion Pharma has reviewed the recent collaboration between NHS England (NHSE), the Medicines and Healthcare products Regulatory Agency (MHRA), and Medicines UK. This joint initiative aims to provide Marketing Authorisation Holders (MAHs) with the opportunity to re-evaluate inactive or “dormant” licences through the newly launched Project Revive: Rapid Reactivation Programme for Dormant Medicines Licences. What […]
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 […]
Super-group vs Workshare variations – what are the differences?
The principle of Super-grouped and Workshare Variations is to make an “identical change(s)” to a number of difference licences via 1 Application form, 1 submission, & 1 Authority assessment. The aim being that it makes it easier to harmonise National MA dossiers across different EU Member States. Also to avoid duplication of work by national […]
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 […]
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 […]
Type IA Variations – A Change to Annual Updates
What is the new process for Type IA Variations in the EU – Annual Reports? Following the implementation of the Delegated Regulation (EU) 2024/1701, on 1 January 2025, there are now changes to the process for submitting Type IA variations. If your Type IA variation was implemented in 2024: it may be submitted no later than […]
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 […]
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 […]