medicines-medical devices-regulatory affairs
About the reliance pilot programme EMA and WHO are supporting a pilot programme that enables pharmaceutical companies to submit EMA-approved post-authorisation changes (i.e. variations) to multiple non-EU national authorities. Why is the reliance pilot programme deemed necessary? Regulatory authorities use reliance extensively when…
Last updated: 3 February 2026 To view updates, click on the ‘+’ sign below. The worksharing procedure for the assessment of Active Substance Master File (ASMF) The document with the above title has been updated. Here, you can view the…
Last updated: 30 January 2026 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: 21 January 2026 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…
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…
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: 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…