Review of generic approvals with regard to potentially falsified bioequivalence studies.
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion that relevant study parameters were deliberately falsified, which is a massive violation of Good Clinical Practice (GCP). This means that generic drugs of different drug classes may have been approved based on potentially falsified study data collected by GVK Biosciences (see BASG safety information on 06.12.2014).
The Federal Office for Safety in Health Care/the AGES Medical Market Inspectorate therefore immediately contacted the marketing authorization holders concerned, who have since submitted additional data regarding the bioequivalence of the marketing authorizations in question from other research service providers, or have voluntarily stopped the delivery of affected preparations until the situation has been clarified or until further bioequivalence studies have been completed by other study test centers.
The submitted data are now being evaluated by the Federal Office for Safety in Health Care/AGES Medical Market Surveillance. In parallel to the national supplementary evaluation procedures in Austria, further marketing authorizations are being subjected to a risk assessment procedure at the level of the European Medicines Agency (EMA), in which AGES is also actively involved.
It should be noted that the marketing authorization status of the medicinal products undergoing further evaluation remains unchanged, i.e. they have a valid marketing authorization and can therefore be marketed at present.
The drugs in question can continue to be used without hesitation, as there are no indications of health risks. In case of doubt, patients should seek medical advice.
Queries (technical): Dr. Christoph Baumgärtel, Tel.: 050555/36004 E-mail: christoph.baumgaertel@ages.at
Queries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
