‘Serious Problem’: EMA Director Criticizes Unpredictable Pharma Submissions

Industry Says Predicting Submission Dates With 100% Accuracy Is Unrealistic

The European Medicines Agency’s executive director said the current practice of companies frequently changing their planned dates for submitting their marketing submission via the centralized procedure was “playing havoc” and was “detrimental to the system.”

Hand of business man sticking out of a desk full of papers and flying papers
Resources In The EU Medicines Regulatory Network Are Stretched To The Limit (Shutterstock)

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