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EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more

Reduction of EU regulatory data protection, but not as short as the European Commission proposed - European Parliament’s position...

On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more

Medicines shortages: Dutch Ministry publishes Policy Rule; EMA calls for MAHs to register contact

With a goal of ensuring medicinal supply interruptions are better managed, the Dutch Ministry’s Policy Rule regarding ‘iron stock’ sets obligations for marketing authorisation holders and wholesalers to keep a minimum safety...more

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