European Medicines Agency’s Scientific Advisory Groups

Published by IRDiRC

Early Access Support Regulatory Affairs EMA Scientific Advisory Group Scientific Advice

SAGs can be convened by the Committee for Medicinal Products for Human Use (CHMP) to provide independent scientific expertise and advice relevant to the evaluation of medicines

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EMA Qualification of novel methodologies for medicine development

Published by IRDiRC

Committee for Orphan Medicinal Products Scientific Advice Early Access Support Regulatory Affairs

The EMA Qualification process is a voluntary, scientific pathway leading to either a CHMP (Committee for Medicinal Products for Human Use) Qualification opinion or a qualification advice on innovative methods or drug development tools

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

Published by IRDiRC

Early Access Support Regulatory Affairs Research and Drug Development Scientific Advice Stakeholder Engagement Healthcare Professional

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 laboratory to patient: the journey of a medicine assessed by EMA

Published by EMA

Regulatory Affairs Marketing Authorisation EU Marketing Authorisation Road Map EMA Drug Development Scientific Advice Committee for Orphan Medicinal Products

This booklet covers medicines for human use that are authorised via EMA through the EU centralised procedure.

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Joint EMA-HTA Scientific Advice

Published by IRDiRC

Scientific Advice Regulatory Affairs EUnetHTA HTA Bodies

The European Medicines Agency (EMA) offers consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA) as of July 2017. This aims to allow medicine developers to obtain feedback from regulators and health technology assessment (HTA) bodies on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time.

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