Fake registration data: AMK demands clarification as quickly as possible

08.12.2014 17:42

According to media reports, the clinical studies required for approval of various medications were falsified. These studies were carried out in India by a contract company that also works for various German manufacturers. More than 100 products could be affected. Prof. Dr. Martin Schulz, Chairman of the Medicines Commission of German Pharmacists (AMK): "We demand the fastest possible clarification. Ensuring the quality and safety of medicines is essential."

It is not yet known whether patients were at risk. Schulz: “Measures up to and including suspension of approval must be initiated immediately in order to avoid risks for patients.” The AMK also calls for on-site inspections by European and national authorities to be increased.