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Every day, vast amounts of data are generated that have the potential to inform and improve medicines regulation. In response, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) established a joint steering group to plan and prioritise actions that leverage big data to support innovation and public health in the European...
The EU Innovation Network (EU-IN) is a working group established to support the European Medicines Regulatory Network (EMRN) in facilitating the development of innovative medicines and associated technologies in the European Union (EU).
This section includes the European Medicines Agency's (EMA) product-specific bioequivalence guidance, which summarises in a standardised format the relevant study design principles for demonstration of bioequivalence.
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).
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...
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 European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the...
European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.