by Dr Lorraine Marsh | Sep 27, 2021 | Brexit, Regulatory Affairs, Regulatory Intelligence
Today we’re looking at renewals submitted for Marketing Authorisations (MAs) granted through the Centrally Authorised Procedure (CAP). For the basics on renewals please see my previous blog. A quick recap on how CAP licences will be handled – also see my...
by Dr Lorraine Marsh | Aug 4, 2021 | Brexit, Regulatory Affairs
Today we are focusing on the Innovative Licensing and Access Pathway (ILAP). What is the ILAP? The ILAP is a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. It aims to accelerate the...
by Dr Lorraine Marsh | Jun 18, 2021 | Brexit, News, Regulatory Affairs
Today we are focusing on the Project Orbis initiative, with a UK slant. What is Project Orbis? Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) involving several other participants. The programme has been set up...
by Dr Lorraine Marsh | May 6, 2021 | Brexit, Regulatory Affairs
Today we’re focusing on the Access Consortium. The trend towards globalisation of therapeutic products industries and the rapid emergence of new technologies in the last decade accompanied with shared global challenges have created an increased need for...
by Sarah Neeson | Apr 26, 2021 | Brexit, News, The Covid Files
On 23 June 2016, the United Kingdom narrowly voted to leave the European Union, a decision which has impacted the lives of millions of people. Once the results of the historic vote were revealed, who would have predicted that the process to leave the European Union...
by Sarah Neeson | Apr 26, 2021 | Brexit, News, The Covid Files
In response to the COVID-19 pandemic, and to prevent the NHS being overwhelmed due to a rapid increase of COVID-19 cases, the UK Government made a decision on 16th March 2020 to put the population of the UK into lockdown. Before the pandemic began, the BBC...
