European Commission, European Medicines Agency and World Health Organization step up cooperation to better protect global public health

News 22/09/2015

New working arrangement will allow timely sharing of non-public information

The European Commission and the European Medicines Agency (EMA) have agreed with the World Health Organization (WHO) to share certain non-public information on the safety, quality and efficacy of medicines already authorised or under review in the European Union (EU), or pre-qualified or under review by WHO.

This cooperation will strengthen communication between the respective organisations and make it easier and quicker to take action to protect public health. The arrangement is expected to accelerate patients' access to new and innovative medicines in the EU, avoid duplication of assessments and improve the authorisation and safety of medicines by involving the best expertise from both sides.

The arrangement further strengthens the collaboration between WHO, the European Commission and EMA who have a long history of scientific and technical collaboration in the context of the International Conference on Harmonisation and the International Pharmaceutical Regulators Forum.

Under the confidentiality arrangement, the organisations involved may share information such as:

This strengthened cooperation started on 1 September 2015.

How useful was this page?

Add your rating