On Friday 24 May, in agreement with the EU Member States and following an opinion from the European Medicines Agency (EMA), the European Commission asked the Member States to suspend the market authorisation of a list of generic medicines tested by the Indian company Synapse Labs, due to insufficient evidence concerning the reliability of the test data.
The decision is based on a scientific assessment carried out by the EMA at the request of the Spanish Medicines Agency. The latter inspected the laboratory and informed the EMA.
The EU has a strict and rigorous drug approval and pharmacovigilance process to ensure the highest standards for medicines in the EU. The EMA considered that the tests carried out by Synapse Labs on these generic medicines did not meet the EU’s strict requirements in terms of evidence to demonstrate that they are equivalent to reference medicines.
In agreement with EU Member States, national market will be suspended until manufacturers can provide valid and reliable data to demonstrate equivalence. This means that data must be provided to show that generic medicines release the same amount of active substance into the body as the reference medicines.
In the meantime, however, to avoid any risk of shortages, national authorities may postpone the suspension of market authorisations for generic medicines.
Link to the list: https://aeur.eu/f/ccu (Original version in French by Lionel Changeur)