www.ema.europa.eu The European Medicines Agency (EMA) is relaunching its corporate website on Tuesday 5 December. From day one, EMA is giving its website a fresh look and feel. The website will also feature a new, simple medicines search, clearer navigation and a revamped What’s new...
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Global regulators celebrate 10 years of strategic leadership and cooperation – www.ema.europa.eu
www.ema.europa.eu This year marks the 10th anniversary of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA was established in December 2013 by eight regulators to address a need for a global governance mechanism and stronger cooperation. Today, ICMRA consists...
Global regulators celebrate 10 years of strategic leadership and cooperation – www.ema.europa.eu
www.ema.europa.eu The anniversary will be celebrated during ICMRA's annual summit and Plenary in Melbourne on 13-16 November, hosted by the Therapeutic Goods Administration (TGA) of Australia. ICMRA members will exchange views and discuss topics such as the use of artificial intelligence...
First electronic product information (ePI) published for selected human medicines – www.ema.europa.eu
www.ema.europa.eu The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). The product information of a medicine includes its...
First electronic product information (ePI) published for selected human medicines – www.ema.europa.eu
www.ema.europa.eu The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). The product information of a medicine includes its...
EMA encourages companies to submit type I variations for 2023 in November 2023 – www.ema.europa.eu
www.ema.europa.eu EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2023 no later than Thursday, 30 November 2023. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 25 December 2023 and 3...