The European Medicines Agency (EMA) announced the review last week.
One centrally authorised pharmaceutical product – Mylan’s version of Cialis (Tadalafil) – and several other drugs whose approval is based on bioequivalence safety evaluation (BSE) data generated by Micro Therapeutic are being re-examined.
The review was prompted by inspections of Micro Therapeutic’s facilities in Chennai and Coimbatore in India conducted in February this year.
The EMA said the findings call into question the "trustworthiness of the data generated by the site between June 2012 and June 2016 and cast doubt on the reliability of the corresponding bioequivalence studies conducted during this period to support a marketing authorisation."
The agency did not provide additional information but did say reviews of this type are triggered by "concerns relating to the quality, safety or efficacy of a medicine or a class of medicines."
ECG and data changing
According to information released by the Austrian Federal Office for Safety in Healthcare (BASG) the concerns include inconsistencies in electrocardiogram (ECG) data that are indicative of ‘intentional misrepresentation.'
BASG also suggested documentation practices at the two labs are not up to code, highlight activities like "overwriting and changing raw data without ensuring the readability of the initial entry" as another major worry.