Regulatory Science

The information proposed in this section provides key elements on the regulation of medicines for Rare Diseases in human and provides support in the:
Health Technology Assessment,
Drug repurposing,
Preclinical suties,
Early access support,
Clinical Development,
Marketing Authorization,
Ethic and legal issues,
Regulatory Agencies.

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EMA Framework for stakeholder’s engagement – patients, academia, healthcare professionals

Published by IRDiRC

Early Access SupportHealthcare ProfessionalRegulatory AffairsResearch and Drug DevelopmentScientific AdviceStakeholder Engagement

The Agency has been interacting with its stakeholders since its inception. These stakeholder relations have evolved over time and the type and degree of interaction is varied depending on the stakeholder groups and fields of Agency activity.

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From lab to patient: journey of a medicine

Published by EMA

Centralised ProcedureCommittee for Orphan Medicinal ProductsEMA Drug DevelopmentEU Marketing Authorisation Road MapMarketing AuthorisationNational ProcedureRegulatory AffairsScientific Advice

Follow the journey of a medicine for human use assessed by EMA in this interactive timeline. It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the Safety of medicines. 

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Paediatric Regulation

Published by EU

Early Access SupportEMA Paediatric RegulationOfficial JournalPaediatric MedicinePaediatric RegulationRegulatory Affairs

The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately and improving the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults.

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