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Europe's CHMP recommends suspension of medicines tested by Panexcell over flawed studies

27 Jul 2020

The European Medicines Agency's human medicines committee (CHMP) has recommended the suspension of European marketing authorizations of generic medicines tested by Panexcell Clinical Laboratories at its site in Mumbai, India, citing irregularities in how the company carried out bioequivalence studies.

The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies, which are used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.

The inspectors found samples from different patients that were exceptionally similar and an instance of personnel documenting the wrong room temperature for the area where samples were being processed.

The EMA said the findings raise serious concerns about the company’s quality management system and the reliability of data from that site.

The CHMP looked at all medicines tested by Panexcell on behalf of EU companies and found none for which adequate data were available from other sources.

"The Committee, therefore, has recommended that all medicines authorised in the EU on the basis of bioequivalence studies conducted by Panexcell be suspended from the market," the EMA said in a statement.

The agency stressed that there is no evidence of harm or lack of effectiveness with any of the affected medicines.

To lift the suspension, companies in the EU relying on data from Panexcell must provide alternative data demonstrating bioequivalence.

In addition, medicines currently being evaluated for authorisation on the basis of data from Panexcell will not be granted authorization in the EU.

The CHMP's recommendation is being sent to the European Commission for a legally binding decision.

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