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EMA To Revamp Pre-Submission Dialog For Smoother Drug Reviews

 
• By Vibha Sharma

The European Medicines Agency is looking at ways to better engage with companies before they submit their drug marketing applications to avoid premature dossiers and have better visibility on planned applications.

Business Employee Asian woman hand working in Stacks paper files for searching and check unfinished document archives on folders papers at busy work desk workplace office. Business Documents concept.
EMA wants to engage earlier with companies to stop them from submitting incomplete dossiers • Source: Shutterstock

The European Medicines Agency is working on a new initiative to improve the way it interacts with drug companies in the pre-submission phase in order to improve the quality of the marketing authorization applications it receives and ensure better MAA predictability.

Key Takeaways

  • The European Medicines Agency is working on a “pre-submission interaction revamp project” to better engage with marketing applicants.

  • The EMA wants to use the pre-submission dialog to improve the quality of marketing authorization applications (MAA) and have better visibility on planned MAA submissions

The new “pre-submission interaction revamp project” will complement several initiatives that the EMA is already running to improve the quality of filings and

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