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New guidance on safety monitoring of medicines in children

EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. The new GVP chapter covers approved medicines with a paediatric indication or with an ongoing paediatric development, but also medicines only approved for adults when they are used off-label to treat children, i.e....

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CHANGES TO EUDRAVIGILANCE REGISTRATION AND MANAGEMENT FROM 26 JULY 2018

On 26 July 2018, the European Medicines Agency (EMA) integrated the services of EudraVigilance (human) with EMA’s Account Management portal icon and Organisation Management Service (OMS). Pharmaceutical companies holding or applying for a marketing authorisation in the European Economic Area (EEA), sponsors of clinical trials and national competent authorities in the...

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