Category European Medicines Agency

Amendments to the EU variations regulation and new variations guidelines

Last updated: 4 March 2026 To view updates, click on the ‘+’ sign below. This post provides information on the changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. Legal Framework What are some of the changes introduced…

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Ongoing EMA and WHO supported reliance pilot programme for the submission of post-authorisation changes to non-EU national authorities

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…

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Opening procedures at EMA to non-EU authorities (OPEN) Framework

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…

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EMA feedback to the EC request to evaluate the feasibility of alternatives to replace TiO2 in medicinal products and its possible impact on the availability of medicines

Last updated: 8 August 2025 To view updates, click on the ‘+’ sign below: The information for this post has been obtained from the report (of 1 April 2024) with the title above, published on 6 August 2025. Whilst the…

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The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms

Last updated: 26 October 2025 See history of updates below. The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project will have a wide ranging and positive impact on industry stakeholders…

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EU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot

Last updated: 27 May 2025 To see updates, click on the ‘+’ sign below The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific…

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