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How To Plan And Submit A Marketing Authorization Application: The EMA Perspective

 
• By Vibha Sharma

Too few marketing authorization applications are submitted to the European Medicines Agency on time, leading to disruption and resourcing difficulties. The Pink Sheet examines initiatives taken in the recent past to address the issue and what companies need to be aware of to ensure the evaluation process is as efficient as possible.

Pushing Barriers
Companies can facilitate the efficient evaluation of their EU drug filings (Shutterstock)
Key Takeaways
  • Throughout 2024, the European Medicines Agency undertook new measures to supplement ongoing efforts to improve the efficiency of the approval process for new medicines in the EU.
  • These measures aim to address concerns over the EMA's inability to accurately predict the number of initial drug marketing authorization applications (MAAs) it can expect to receive from companies, which is impacting the agency's resources.
  • The initiatives introduced in 2024, and earlier, complement the EMA’s best practice guidance on how companies should plan and time the submission of their MAAs.
  • Companies can support the evaluation process by understanding why and how long it takes the EMA to make certain key decisions about an expected MAA, being realistic about when a MAA dossier may be ready for submission and using every opportunity to interact with the agency in the pre-submission phase.
  • More initiatives are planned for 2025, including a project to improve pre-submission interactions with companies to ensure they submit mature dossiers and to improve the predictability of MAA submissions.

Although there are many uncertainties in drug development that can impact a product’s approval, companies can follow certain best practices to ensure a smooth evaluation of their marketing authorization applications...

Having clarity on why and how long it takes the European Medicines Agency to make certain key decisions about an expected MAA, being realistic about when an MAA dossier may...

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