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 […]
Updated MHRA Scientific Advice Process (+ case study)
Why might I need a Scientific Advice Meeting? Do you have any questions for the MHRA about the clinical development of your medicine, strategy for a Marketing Authorisation Application (MAA) or looking at a reclassification? Then you may benefit from a scientific advice meeting (SAM) with the MHRA. This article provides an outline of where […]
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 […]
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 […]
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 […]