medicines-medical devices-regulatory affairs
Last updated: 28 April 2025 To see updates, click on the ‘+’ sign below. How were these reforms developed? The reforms were developed through a series of stakeholder workshops, seeking the views of a wide range of organisations and individuals…
Last updated: 1 April 2025 This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021 Click on the ‘+’ sign next to each heading to access the information under each…
Last updated: 26 March 2025 To view updates, click on the ‘+’ sign below. What is POC manufacturing? POC manufacturing refers to the manufacture of personalised medicines made for the patient either within or very close to where they are…
Last updated: 14 March 2025 To view updates, click on the ‘+’ sign below. This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guideline. Timeline of events leading to the publishing of…
The MHRA has provided a link to the webinar of Tuesday 15 October 2024 on Implementing the new UK Clinical Trials regulations. This webinar details the upcoming implementation of new clinical trial regulations in the UK. How you might use…
Last updated: 18 April 2024 See updates below On 26 April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable and innovative medicines. This was covered in a previous post. This post is an attempt to…
Last updated: 12 April 2024 See updates at the end of the post The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and adapted…