The European Medicines Agency (EMA) has started a review of approved medicines supported by clinical date provided by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India.
The review follows an inspection which raised concerns about the reliability of study data provided by the company and used to support licence applications for several medicines in the EU. The inspection was carried out jointly by Austrian and German authorities in October 2019 in the context of the evaluation of an application for marketing authorisation of a medicine.
Having considered the inspection findings, the German medicines agency expressed serious concerns about Panexcell studies and requested the EMA to assess the impact of these findings on the benefits and risks of medicines that have been authorised in the EU on the basis of such data. The review will cover medicines authorised or currently being evaluated via national procedures on the basis of studies conducted by the company.
The review is being carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The CHMP's opinion will be forwarded to the European Commission, which will issue a final legally-binding decision applicable in all EU Member States.