medicines-medical devices-regulatory affairs
What is the OPEN framework? The European Medicines Agency (EMA) collaborates with medicine regulators outside the European Union (EU) in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities). Brief history of the OPEN framework Date Event Dec…
Last updated: 20 January 2026 To view updates, click on the ‘+’ sign below: On 16 December 2025, the European Commission proposed a targeted simplification of the current rules for medical devices to make them easier, faster and more effective…
Last updated: 13 January 2026 To view updates, click on the ‘+’ sign below. For a basic introduction to IDMP, watch this clip from the Uppsala Monitoring Centre, Sweden. Some more information is available in this blog post. The EU…
This post is an attempt to provide salient information on Case C-118/24 concerning EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS vs the French Regulatory Authority (the ANSM) and Eli Lilly. Specifically, it concerns the opinion of Attorney General…
Last updated: 8 January 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 December 2025 To view updates, click on the ‘+’ sign below. The table below is an attempt to present some court cases involving Supplementary Protection Certificates. You can read more about Supplementary Protection Certificates (SPCs) and Supplementary…
Date Guidance No About the guidance 19 Dec 2025 MDCG 2025–10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025) Unless otherwise stated, this guidance is applicable to all medical devices (MDs) and in…
Last updated: 18 December 2025 To view updates, click on the ‘+’ sign below. Highlights from the Clinical Trials Coordination Group (CTCG) plenary meeting On 3–4 November 2025, CTCG met at EMA to discuss initiatives aimed at streamlining clinical trial…
Date Title of guidance and link to document Type and levelof guidance About the guidance 17 Dec 2025 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Medical Devices) Further reading:FDA finalizes real-world evidence guidance for device sponsors,…
Patients in the UK and Singapore could gain faster access to cutting-edge healthcare innovations under a new partnership bringing two globally respected regulators together with one of the world’s leading biotech creators. As part of this first-of-its-kind regulatory collaboration between…
Last updated: 23 December 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: 23 December 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…