PRIME: priority medicines
EMA's 5-year report on the PRIME scheme provides a detailed analysis and review of the Agency's experience with the scheme in its first five years of application.
It looks at how the scheme helped developers prepare for marketing authorisation assessments, comparing PRIME products to equivalent non-PRIME products.
The report shows that the PRIME scheme can help speed up patient access to new medicines that target an unmet medical need. Applicants supported by PRIME, particularly SMEs, were able to answer questions from EMA's scientific committees in shorter timelines.
It also calls for further improvements, including consideration of the best timepoint for applicants to enter the PRIME scheme, increasing the flexibility of scientific advice provision, and helping applicants better prepare for the marketing authorisation assessment phase.
The report covers data collected between March 2016 and June 2021.
For more information, see Key benefits for applicants.
To read the report, click on the thumbnail image in this section or find the document listed below.
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