Brussels, 24 May 2024
In agreement with EU Member States, and following an opinion by EMA, the Commission has today requested Member States to suspend the marketing authorisation for a list of generic medicines tested by the Indian company Synapse Labs, due to insufficient evidence about the reliability of testing data. The Decision is based on a scientific assessment by the European Medicines Agency (EMA) which was conducted after a request of the Spanish medicines agency. The latter had conducted an inspection of the laboratory and informed EMA, who carried out a review.
The EU has a stringent and rigorous medicines approval and pharmacovigilance process to ensure the highest standards of medicines in the EU. Following its scientific assessment, EMA has established that Synapse Labs’ tests on these generic medicines did not meet the EU’s strict evidence requirements to demonstrate that they are equivalent to the reference medicines.
In agreement with EU Member states, the national market authorisations will be suspended until valid and reliable data can be provided by the manufacturers to show the equivalence. This means providing data to show that the generic medicines release the same amount of active substance in the body as the reference medicines.
In the meantime, however, to avoid any risk of shortages, national authorities may postpone the suspension for up to 2 years for medicines that they consider of critical importance nationally. Similar periods have been granted in the past to secure supplies of medicines of a critical nature. Manufacturers will thus have the time to prepare the necessary data and submit it for assessment. This transition period balances the need for this important data on medicines marketed in the EU, with the need of a continuous supply of critical medicines for patients.
The Commission will continue to closely follow this situation, in cooperation with all Member States.
Source – EU Commission