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Biologicals: Active substance

Published by EMA

Active Substance Biologicals Comparability and Biosimilarity Plasma Master File Plasma-Derived Medicinal Product Vaccine

The European Medicines Agency’s scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

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Commercialisation Pathway Simplified with New Regulatory Roadmap for RNA Therapeutics and Vaccines

Published by Catapult

RNA Vaccines

The roadmap aims to help innovators developing new therapies and vaccines understand regulatory guidance, how to identify the most relevant information to them and how to access support for bespoke interpretation of the guidance

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Biologicals: Finished product

Published by EMA

Biologicals Comparability and biosimilars Gene Therapy Genetically Modified Organism Investigational Medicinal Product Lifecycle Management Pharmaceutical Development Plasma derived medicinal products Product Information

The European Medicines Agency’s scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

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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.

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Biologicals: Active substance

Commercialisation Pathway Simplified with New Regulatory Roadmap for RNA Therapeutics and Vaccines

Biologicals: Finished product