EMA Phases out Follow-Up Measures
The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.
The European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP) have started to classify all post-authorization measures for human medicines as it phases out follow-up measures to marketing authorizations. The new classification system is being phased in a stepwise manner. Post-authorization measures will be classified as either: conditions in Annex II (obligations or specific obligations to fulfill post-authorization measures); additional pharmacovigilance activities in the risk-management plan; or recommendations for further development.
EMA and CHMP are reclassifying all outstanding unclassified follow-up measures, starting in August 2012. The first phase of the new classification system tackled initial marketing-authorization-application opinions as of June 2011, followed by post-authorization procedures starting in November 2011.
According to EMA, “Follow-up measures were measures applied to marketing authorizations, setting out studies and other activities that the Agency and CHMP had asked the marketing-authorization holder to perform.” Affected marketing-authorization holders will receive an outcome fax that includes information about the new classification for each of their applicable products.
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.
