Medicinal products for human use

HMA/ema multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations

6. August, 2026 / Artificial intelligence (AI), Medicinal products for human use, Public announcement, Uncategorized

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) will jointly host the multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations on 12 and 13 November 2026. The event will be held in a hybrid format, with in-person attendance (by invitation only) and online participation available. Coordinated by the Network Data Steering Group (NDSG) in collaboration with the CHMP Methodology Working Party and the ACT EU initiative, the forum offers a valuable opportunity to […]

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AI research priorities survey

8. October, 2025 / Artificial intelligence (AI), Medicinal products for human use, Notices to marketing authorization holders, Public announcement

The joint HMA-EMA Network Data Steering Group (NDSG) is running an EU survey to inform research priorities for AI use in the development and evaluation of medicines. To access the

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HMA / EMA multi-stakeholder workshop on artificial intelligence in medicines

8. October, 2025 / Artificial intelligence (AI), Medicinal products for human use, Public announcement

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) will host a multi-stakeholder workshop on artificial intelligence (AI) on 20 and 21 November 2025. The workshop has

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EU strengthens support for non-commercial sponsors of clinical trials

30. September, 2025 / Medicinal products for human use

The Accelerating Clinical Trials (ACT EU) initiative aims to identify gaps, issues and bottlenecks (regulatory, resourcing, operational) that prevent non-commercial sponsors from setting up and conducting clinical trials and multinational

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Upcoming ACT EU Multi-Stakeholder Platform Annual Meeting

30. September, 2025 / Dogodek, Medicinal products for human use, Obvestila za imetnike dovoljenj za promet

The Accelerating Clinical Trials in the EU (ACT EU) initiative will hold its annual Multi-Stakeholder Platform meeting on 29 October 2025. The event, organised by EMA, will gather regulators, academia,

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New labelling requirements for metered dose inhalers containing fluorinated greenhouse gases

2. October, 2024 / Medicinal products for human use, Notices to marketing authorization holders

In relation to Commission Implementing Regulation (EU) 2024/2174 of 2 September 2024 laying down rules for the application of Regulation (EU) 2024/573 of the European Parliament and of the Council

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New version of the Clinical Trials Information System (CTIS) public portal

19. June, 2024 / Medicinal products for human use, Public announcement

We are pleased to announce the launch of a new version of the Clinical Trials Information System (CTIS) public portal, which will allow earlier and more efficient access to clinical

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JAZMP AVAILABLE TO ACT AS REFERENCE MEMBER STATE (RMS) IN MRP AND DCP PROCEDURES

21. July, 2023 / Medicinal products for human use, Notices to marketing authorization holders

JAZMP is ambitious to further actively participate in assessment of marketing authorisation applications. In order to strengthen Slovenia’s position in the regulatory EU environment, one of the strategic objectives of

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JAZMP AVAILABLE TO ACT AS REFERENCE MEMBER STATE (RMS) IN MRP AND DCP PROCEDURES

17. June, 2022 / Medicinal products for human use, Notices to marketing authorization holders

JAZMP AVAILABLE TO ACT AS REFERENCE MEMBER STATE (RMS) IN MRP AND DCP PROCEDURES Read More »

Call on marketing authorisation holders to provide information about product codes (PC)

3. December, 2019 / Medicinal products for human use, Notices to marketing authorization holders

The stabilisation period in Slovenia, introduced after the implementation of Commission Delegated Regulation 2016/161, ended on 1st of December 2019. Therefore the Agency for Medicinal Products and Medical Devices of

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HMA/ema multistakeholder AI and Data forum: Build trustworthy AI on strong data foundations

AI research priorities survey

HMA / EMA multi-stakeholder workshop on artificial intelligence in medicines

EU strengthens support for non-commercial sponsors of clinical trials

Upcoming ACT EU Multi-Stakeholder Platform Annual Meeting

New labelling requirements for metered dose inhalers containing fluorinated greenhouse gases

New version of the Clinical Trials Information System (CTIS) public portal

JAZMP AVAILABLE TO ACT AS REFERENCE MEMBER STATE (RMS) IN MRP AND DCP PROCEDURES

JAZMP AVAILABLE TO ACT AS REFERENCE MEMBER STATE (RMS) IN MRP AND DCP PROCEDURES

Call on marketing authorisation holders to provide information about product codes (PC)

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