medicines-medical devices-regulatory affairs
Last updated: 15 July 2025 To view updates, click on the ‘+’ below. The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year. Applicants…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Jun 2025 (Medical Devices) Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Final This guidance is applicable to devices with…
Last updated: 1 July 2025 To view updates, click on the link below: Switzerland is considered a leading research locations for clinical trials. What is at the core of the fast-track procedure? At the core of the fast-track procedure will…
Last updated: 28 June 2025 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: 27 June 2025 To view updates, click on the ‘+’ sign below. What is COMBINE? COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research. When did the COMBINE Project 1 –…
Last updated: 23 June 2025 To view updates, click on the ‘+’ sign below. Report and minutes from the CMDh meeting held on 20-21 May 2025 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of…
Date Guidance No About the guidance 19 Jun 2025 MDCG 2025-6 FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025) This document provides a first set of…
Last updated: 20 June 2025 To view updates, click o the ‘+’ sign below. The UK launched the regulatory Innovative Devices Access Pathway (IDAP) in September 2023. About the Innovative Devices Access Pathway (IDAP) The aim of IDAP is to enable and…
Swissmedic enshrines the requirement to submit risk assessments regarding nitrosamines in active substances and/or finished medicinal products in the relevant specification documents. Update 18 June 2025 Source: Swissmedic
Last updated: 9 June 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…
Last updated: 16 June 2025 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 taker a closer…
Last updated: 12 June 2025 To view updates, click on the ‘+’ sign below. 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…