August 5, 2025Drug Discovery TodayOpen Access

Learning from the EMA experience: common CMC deficiencies in marketing authorisation applications over the past decade

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Common deficiencies in marketing authorisation applications impact the approval speed of new drugs.
Major objections raised during 10 years of reviews reveal trends according to product types and health crises.
The centralised procedure in the EU often faces issues tied to evolving legal frameworks and guidance updates.
Understanding these deficiencies can enhance compliance and facilitate quicker patient access to essential drugs.

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Implication

This review identifies common deficiencies in marketing authorisation applications for new drugs in the EU, highlighting implications for drug approval processes.

Cite This Study

Ossa et al. (2025) studied this question.

synapsesocial.com/papers/689a0f93e6551bb0af8d1285 https://doi.org/10.1016/j.drudis.2025.104444

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Implication

This review identifies common deficiencies in marketing authorisation applications for new drugs in the EU, highlighting implications for drug approval processes.

Learning from the EMA experience: common CMC deficiencies in marketing authorisation applications over the past decade

Key Points

Discussion

Implication

Cite This Study

Learning from the EMA experience: common CMC deficiencies in marketing authorisation applications over the past decade

Key Points

Discussion

Implication

Cite This Study

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Also Consider