blog
Digital Health Series – Part 4: Software as a Medical Device Regulated by the UK
Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is…
blog
The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization
Following the UK’s departure from the EU In 2021, the MHRA has introduced several initiatives to foster product development and…
webinar
Ask the Experts: MHRA’s Innovative Licensing and Access Pathway (ILAP)
In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming…
presentation
How to overcome the regulatory challenges due to BREXIT
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th 2020. We shared our insights and thoughts…
blog
Update on The Redistribution of UK’s portfolio of centrally authorised products
In preparation for Brexit, the 27 EU Member States, together with the European Medicines Agency (EMA), have reached a major…
blog
EU Downplays likelihood of UK staying in EMA after Brexit
In draft guidelines prepared by the President of the European Council, and published on 7 March 2018, the European Council…
blog
Brexit update: EMA & Join Trade Association Meeting on 23rd March 2018
We are on the home-straight to Brexit! Just one year (30th March 2019), to the official date in which the United…
publication
Brexit: The legal and regulatory impact on supply chain and pharmacovigilance
The UK will withdraw from the EU on 29 March 2019. By 1 August 2018, no agreement had been reached…
