medicines-medical devices-regulatory affairs
Medical Devices (MD) registration When will the registration of Medical devices and procedure packs in Swissdamed become mandatory and replace the notification obligation and is there a transition period? The registration of devices, systems, and procedure packs according to Art.…
Last updated: 28 March 2026 Below is an attempt to provide information on the new clinical trials regulations. The information is by no means complete or exhaustive. Please use this post as a starting point and take the time to…
Last updated: 28 March 2026 To view updates, click on the ‘+’ sign below: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure Here, you and view the tracked changed (Dec 2025) and clean (Mar 2026) versions…
Date Title of guidance and link to document Type and levelof guidance About the guidance 27 Mar 2026 Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Final This guidance provides recommendations on how voluntary “patient preferenceinformation” (PPI)…
This post covers international regulatory news in brief. It is updated on an ad hoc basis. For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab.…
Last updated: 26 March 2026 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: 24 March 2026 To view updates, click on the ‘+’ sign below: MHRA and NICE are launching an aligned pathway together with an improved Integrated Scientific Advice service to accelerate patient access to medicines and provide a more…
Last updated: 24 March 2026 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the following: Below is an attempt to lay out the guidance in a in an easy…
What action(s) is the MHRA taking in order to phase out animal testing? The MHRA has taken decisive action to phase out animal testing by helping developers to make greater use of New Approach Methodologies (NAMs). By offering early review…
Last updated: 23 March 2026 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…
Last updated: 14 March 2026 To see updates click on the ‘+’ sign below. This post is an attempt to provide basic information on some Artificial Intelligence (AI) based chatbots, search engines and other AI based software. Chatbot/search engine Company…
Last updated: 9 March 2026 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…