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Medicines approval and regulation in the EU

Medicines approval and regulation in the EU content

The European Medicines Agency (EMA) is responsible for the approval and regulation of medicines across all European Union member states and the European Economic Area (EEA), which includes Norway, Iceland, and Liechtenstein. This involves the scientific evaluation, supervision and safety monitoring of medicines for both human and animal health. The EMA’s role is to ensure that all medicines available on the EU market are safe, effective and of high quality.

How is a medicine assessed?

Most medicines in the EU are assessed under the centralised procedure. This requires the manufacturer of the medicine to submit a single application to the EMA. This application will contain a large amount of scientific evidence, including results from clinical trials. The medicine is then assessed by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Other committees will also feed into this process as required, for example in relation to risk assessment or advanced therapies. The CHMP will give a positive or negative opinion on the medicine based on this scientific assessment. If the medicine receives a positive opinion, the EMA will send a recommendation to the European Commission (EC) to approve the medicine. The European Commission will grant a license, called marketing authorisation, so that the company can market the medicine in all EU and EEA countries. The EMA takes approximately one year to evaluate a medicine and the EC grants marketing authorisation approximately two months after receiving the positive CHMP opinion.

The EMA have created this short video explaining how a medicine is approved.

You will find more in-depth information about the EMA’s medicines approval and regulation processes in the booklet “From laboratory to patient: the journey of a centrally authorised medicine“.

Once a medicine has been approved at the European level, a company must then submit a separate application for reimbursement at a national level in each country. Click here to learn about medicines approval and reimbursement processes in Ireland.