medicines-medical devices-regulatory affairs
Last updated: 3 April 2025 To view updates, click the ‘+’ sign below. This post is an attempt to present the guidance on the scheme for Conditional Marketing Authorisations in a Q&A format. Always read the information on this procedure…
Last updated: 3 April 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on the scheme for Conditional Marketing Authorisations in a Q&A format. Always read the information on this…
Last updated: 3 April 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on the Unfettered Access Procedure (UAP) for marketing authorisations approved in Northern Ireland in a Q&A format.…
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: 31 March 2025 To view updates, click on the ‘+’ sign below: Update – MedEthicsEU report – Survey on National Part II Clinical Trial Application (CTA) requirements (March 2025) Overview part II requirements in a Clinical Trial application…
Last updated: 31 March 2025 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Technology Appraisal Bodies (the All Wales…
Last updated: 27 March 2025 See updates at the end of the post. The African Medicines Agency’s (AMA) long journey towards harmonization started in 2009 with the establishment of the African Medicines Regulatory Harmonisation Initiative (AMRH) and the involvement of…
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: 25 March 2025 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: 25 March 2025 See updates below. This post is an attempt to provide basic information about the Access Consortium, a collaborative initiative of regulatory agencies. Click on the ‘+’ sign next to each heading to access the information…