EMA Protocol Assistance (i.e., Scientific Advice for Orphans)

Published by IRDiRC

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

The EMA protocol assistance is the scientific advice of the Committee for Human Medicinal Products (CHMP) along with Committee for Orphan Medicinal Products (COMP), particularly designed for products that have orphan drug designation status.

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EMA Qualification of novel methodologies for medicine development

Published by IRDiRC

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

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

Published by EMA

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

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

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From lab to patient: journey of a medicine

Published by EMA

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

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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