Browse Resources

REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2003

Published by EC

Advanced Therapy Marketing Authorisation

This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.

View this resource Bookmark this resource

EMA pre-submission meeting (Pre-MAA meetings)

Published by IRDiRC

EU Marketing Authorisation Road Map MAA Pre-Submission MAA Submission Marketing Authorisation Regulatory Regulatory Affairs

MAA Pre-submission meeting is not a mandatory meeting, however, it is strongly recommended as it is the final meeting before the registration (MAA submission) where the developer address product- specific legal, regulatory and scientific issues

View this resource Bookmark this resource

Conditional Marketing Authorization

Published by IRDiRC

Conditional Marketing Authorisation Marketing Authorisation Regulatory Affairs

The CMA allows a fast access to medicines for patients, which fulfil an unmet medical need

View this resource Bookmark this resource

Accelerated assessment

Published by IRDiRC

Accelerated Assessment Centralised Procedure Marketing Authorisation Regulatory Affairs

The accelerated assessment allows a faster assessment process for the marketing authorization application under the Centralised Procedure

View this resource Bookmark this resource

Marketing Authorization under Exceptional circumstances

Published by IRDiRC

Exceptional Circumstance Marketing Authorisation Regulatory Affairs

The MAUEC enables the marketing authorization of medicines for which the applicant would otherwise be unable to provide comprehensive data on the efficacy and Safety under normal conditions due to reasons of extreme rarity of the condition, technical impossibility to generate comprehensive knowledge, or ethical constraints.

View this resource Bookmark this resource

EMA Marketing Authorization (MA) with conditions

Published by IRDiRC

Efficacy Data EMA Conditional Marketing Authorisation Marketing Authorisation Regulatory Affairs Safety Data

A marketing authorisation may be granted with certain conditions in order to ensure the collection of additional Safety and or efficacy data.

View this resource Bookmark this resource

From lab to patient: journey of a medicine

Published by EMA

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

View this resource Bookmark this resource

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

Published by EMA

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

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

View this resource Bookmark this resource

The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

IMT Feedback

Did the IMT help you in finding the resource you needed?

REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2003

EMA pre-submission meeting (Pre-MAA meetings)

Conditional Marketing Authorization

Accelerated assessment

Marketing Authorization under Exceptional circumstances

EMA Marketing Authorization (MA) with conditions

From lab to patient: journey of a medicine

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