What is the EMA?

The European Medicines Agency – EMA is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. Since its foundation in 1995, the EMA has been engaging in dialogue with European patients and consumers.

To find out more on how the European regulatory system for medicines operates, we invite you to download the EMA booklet by clicking here. It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network – a partnership between the European Commission, the medicines regulatory authorities in EU Member States and the European Economic Area (EEA), and the European Medicines Agency (EMA) – works to ensure that patients in the EU have access to high-quality, effective and safe medicines.

How patients organisations collaborate with the EMA?

During ECPC AGM2014, EMA representative Nathalie Bere thoroughly explained to the audience the role of patients and consumers within the Agency. You can download her presentation clicking here.

How ECPC collaborates with the EMA?

ECPC collaborates within the EMA since 2013, when it passed the strict EMA eligibility criteria to become a Member of the Patients’ and Consumers’ Working Party of the Committee for Medicinal Products for Human Use (CHMP).

The CHMP provides recommendations to the European Medicines Agency and its human scientific committees on all matters of interest to patients in relation to medicinal products.

ECPC Vice President Kathi Apostolidis and ECPC former Board Member Rafal Swierzewski are our representatives in the CHMP. Their main task is to extend an intensive cooperation between cancer patients and the European Medicines Agency, so that cancer patients are strongly involved in all possible procedures within EMA (e.g. benefit/risk assessment in Scientific Advise procedures; Package Leaflets assessment; participation in Scientific Advisory Group in case of oncology).

Patients’ contribution is very important also for pharmacovigilance e.g. adverse drug reaction reporting as well as pushing national authorities to implement all rules of the Pharmacovigilance Directive.