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The European Medicines Agency (EMA) publishes opinions on the qualification of innovative development methods and letters of support for novel methodologies that have been shown to be promising in the context of research and development into pharmaceuticals.
A range of services is available from the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and European Commission to support innovative medicines and associated technology developments in the European Union (EU).
The Network Data Steering Group (NDSG) combines the former Big Data Steering Group and the Network Data Board into one data governance group. It aims to optimise data use and management in medicines regulation. This is for the benefit of public and animal health in the European Union (EU). The European Medicines Agency (EMA) and Heads of Medicines...
PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach...
The main objective of the small and medium-sized enterprises (SME) Regulation (Commission Regulation (EC) No 2049/2005) is to provide financial and administrative assistance to these enterprises through the SME office of the European Medicines Agency (EMA). It also aims to address the needs of smaller companies in the pharmaceutical sector.
This page includes information on periodic safety update reports (PSURs), PSUR submission requirements, PSUR single assessment procedures (PSUSAs) and the European Union reference dates (EURD) list.
Following the positive evaluation of a plasma master file (PMF) under the PMF certification scheme, the European Medicines Agency (EMA) issues a certificate of compliance with European legislation which is valid throughout the European Union. EMA publishes the list of all the issued PMF certificates.
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short...