EMA Issues Guideline on Fast Tracking Drugs for Unmet Needs
EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.
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.
Source: EMA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
