The European Commission has requested member states to suspend marketing authorizations for a list of generic drugs tested by Synapse Labs due to insufficient evidence regarding the reliability of testing data.
The Human Medicines Committee (CHMP) of the European Medicines Agency (EMA) has confirmed its recommendation to suspend or not grant marketing authorizations for a number of generic drugs tested by Synapse Labs, based on a scientific evaluation carried out by the EMA following a request from the Spanish Medicines Agency.
In the meantime, to avoid any risk of shortages, national authorities may postpone the suspension for up to 2 years for medicines that they consider to be of critical national importance.
Manufacturers will thus have time to prepare the necessary data and submit it for evaluation
The Commission has stated that it will continue to closely monitor this situation in cooperation with all member states.
The CHMP adopted the initial recommendation in December 2023, following a Good Clinical Practice (GCP) inspection that revealed irregularities in study data and inadequacies in study documentation and computerized study data management systems and procedures. This raised serious concerns about the data from bioequivalence studies conducted by the Indian laboratory.
Additional Notes:
The suspension of these generic drugs could lead to shortages and higher prices for some patients.
The EMA is investigating the matter further and will take appropriate action if necessary.
Patients are advised to talk to their doctor if they have any concerns about their medication.
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