All European Medicines Agency (EMA) articles – Page 2

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    Journal

    G-E-T-ting there – how gene editing technologies could change more than genes

    2023-05-18T12:57:00Z

    The field of genome editing technologies (GETs) is rapidly advancing, marking a new and exciting era of curative medicines. These products can alter genetic material in patients, highlighting the crucial need to introduce dedicated legislation to ensure that GETs are developed and maintained in a safe and effective manner.

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    Journal

    Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR

    2023-01-04T10:39:00Z

    European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.