medicines-medical devices-regulatory affairs
Last updated: 20 November 2024 To see updates, click on the ‘+’ sign below The Windsor framework was covered in a previous post. The guidances in the table below are covered in this post. Only a snapshot of each guidance…
Last updated: 20 November 2024 To see updates, click on the ‘+’ sign below: Understanding how to use AI based chatbots or search engines to search for information is important in order to improve your chances of getting a better…
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: 12 November 2024 To see updates, click on the ‘+’ sign below Anyone who has worked on licensing medicinal products in the AsiaPac, LatAm and MEA regions will quite likely have encountered the requirement to obtain a legalised Certificate…
Last updated: 9 November 2024 See updates at the end of this post. The UK MHRA has published guidance on the the Innovative Licensing and Access Pathway (ILAP) for medicines. The pathway brings together innovative approaches to support the safe,…
Last updated: 9 November 2024 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…
The ILAP first launched in January 2021 to offer an integrated pre-market pathway awarding an Innovation Passport for promising medicines across England, Scotland and Wales. The pathway has seen an unprecedented number of applications and 160+ Innovation Passports have been…
Last updated: 6 November 2024 To see updates, click on the ‘+’ sign below. FDA is establishing the Split Real Time Application Review (STAR) pilot program under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. This post is…
The UKs Dept. of Health and Social Care (DHSC) has published a policy paper entitled Design for Life roadmap. In tackling the above problem statements, the programme seeks to achieve 4 primary objectives. These are: Source: gov.uk
Last updated: 28 October 2024 Click on the + sign below to see the updates to this post. On 27 February 2023, the European Commission and the Government of the United Kingdom announced a political agreement in principal on a…