Key European Medicines Agency (EMA) Resources

Key resources from European Medicines Agency (EMA) that facilitates the development of medicines, gene and cell therapy can be found here:

Journey of a medicine

Journey of a medicine

Journey of a medicine

ATMP overview

EMA infosheet

EMA tools infosheet for medicine developers

EMA tools infosheet

EMA Quality Flowchart

EMA Quality Flowchart

Quality Flowchart

Non-clinical Development Flowchart

Non-clinical Development Flowchart

Non-clinical Development Flowchart

Clinical Development Flowchart

Clinical Development Flowchart

Clinical Development Flowchart

EMA Guidelines relevant for advanced therapy medicinal products

EMA

Support for advanced therapy developers

Scientific guideline on the risk-based approach applied to ATMPs

EMA pilot programme for academic and non-profit ATMP developers

Strategies to identify and mitigate risks for first-in-human and early clinical trials with IMPs

EMA certification procedures for micro-, small- and medium-sized enterprises

Back to: Key Pathway Resources

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