EMA Published New Drug Authorization Reports for 2019

| By | EMA

EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use and veterinary medicines.

Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. In 2019, EMA recommended 66 medicines for human use for marketing authorisation. Of these, 30 had a new active substance which had never been authorised in the EU before. The infographic includes a selection of medicines that represent significant progress in their therapeutic areas.

Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action when needed. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches. An overview of some of the most notable recommendations is also included in the document.

In 2019, EMA recommended 15 veterinary medicines for marketing authorisation, an increase of 50% compared to 2018. Of these, five had a new active substance. Four are vaccines, including one new biotechnological vaccine.

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