This page provides answers to specific questions from companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver. Information is also available for companies that already have an agreed PIP.

HumanRegulatory and procedural guidancePaediatricsResearch and development

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...

HumanVeterinaryCorporateData on medicinesInnovationResearch and development

The Cancer Medicines Forum (CMF) aims to explore how EMA can contribute towards addressing remaining uncertainties about the use of cancer medicines in clinical practice.

EventHumanMedicinesResearch and development

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.

HumanVeterinaryCompliance and inspectionsRegulatory and procedural guidanceResearch and development

These questions and answers address a number of questions on matters related to the quality of medicines.

HumanVeterinaryRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines

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).

HumanVeterinaryRegulatory and procedural guidanceInnovationResearch and developmentScientific advice

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...

HumanEarly accessRegulatory and procedural guidanceResearch and development