EU Innovation Network (EU-IN)

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).

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HumanVeterinaryRegulatory and procedural guidanceInnovationResearch and developmentScientific advice
PRIME: priority 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...

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HumanEarly accessRegulatory and procedural guidanceResearch and development
Plasma master file certificates

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.

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HumanRegulatory and procedural guidanceResearch and development
Big data

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...

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HumanVeterinaryCorporateData on medicinesInnovationResearch and development
EudraVigilance training and support

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...

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HumanRegulatory and procedural guidancePharmacovigilanceResearch and development
Mutual recognition agreements (MRA)

The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines.

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HumanVeterinaryCompliance and inspectionsRegulatory and procedural guidanceResearch and development