Category European Medicines Agency

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

Last updated: 28 February 2024 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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EMA and FDA launch pilot program for parallel scientific advice (PSA) for hybrid products and complex generic products

Last updated: 7 February 2024 See updates at the end of the post. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of…

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Using the outcome of Case T-611/18 (Pharmaceutical Works Polpharma S.A vs the EMA) to better understand aspects of EU medicines legislation

Last updated: 21 December 2023 See updates at the end of the post. The parties involved in the case The parties involved in this case were Pharmaceutical Works Polpharma S.A versus the European Medicines Agency (Case T-611/18) supported by the…

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EMA feedback to EC on the impact of the removal of TiO2 from the list of authorised food additives in medicinal products

Last updated: 28 November 2023 See updates at the end of the post. In September 2021, the European Medicines Agency (EMA) provided final feedback to the European Commission (EC) on its request to evaluate the impact of the removal of…

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EMA technical and procedural guidance on the replacement/removal of titanium dioxide (TiO2) in medicines

Last updated: 28 November 2023 See updates at the end of the post. The European Medicines Agency (EMA) has published technical and procedural guidance on the replacement/removal of titanium dioxide (TiO2) in medicines. The guidance is provided under the following…

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