Synapse Labs Pvt. Ltd: The European Medicines Agency recommends suspension of medicines over flawed studies

5 gennaio 2024 – The European Medicines Agency’s (EMA) Human Medicines Committee (CHMP) has recommended the suspension of the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India. The recommendation follows a good clinical practice (GCP) inspection which showed irregularities in study data and inadequacies in study documentation and in the computer systems and procedures to appropriately manage study data. This raised serious concerns about the validity and reliability of data from bioequivalence studies conducted at the CRO. Such studies are carried out to show that a generic medicine releases the same amount of active substance in the body as the reference medicine.

For more information, see here.