EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs

Print 05 August 2015
BioPharm International

The European Medicines Agency (EMA) announced on July 27, 2015 that it has revised its guideline on the implementation of accelerated assessment and conditional marketing authorization to improve existing framework. These guidelines are part of European legislation targeting the acceleration of patient access to innovative therapies.

Changes to the guidelines regarding accelerated assessment include information on how to justify the fulfillment of a major public health threat, optimization of the assessment timetable, and an emphasis on early communication with EMA.

In regards to conditional marketing authorization, the revised guideline also emphasizes the importance of early communication and planning. The revised guideline includes:

• Explanation on fulfillment of unmet medical needs
• “Clarification of how a positive benefit-risk balance is to be substantiated where there are less complete data, with further guidance on the level of evidence that must be provided at the time of authorization and the data that can be provided after authorization”
• Clarification on the extent and type of data required for annual renewal submissions.

The revisions came after experience the agency gained from the implantation of accelerated assessment and marketing authorization in the past [How many?] years as well as discussions with the European Commission Expert Group on Safe and Timely Access to Medicines for patients.

Public consultation on the revised guidelines is open until Sept. 30, 2015. 

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