15-17 October 2019
On April 29, 2016, the European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted at Semler Research Centre Private Ltd, Bangalore, India. This follows an FDA inspection that identified several issues at Semler’s bioanalytical site, including the substitution and manipulation of subjects’ clinical samples. The World Health Organization (WHO) has also raised serious concerns regarding data integrity and manipulation of study samples, following its own inspections of Semler’s bioanalytical and clinical sites.
Semler performs bioequivalence studies for medicines. Bioequivalence studies usually form the basis for authorising generic medicines.
In the EU, several medicines have been authorised through national procedures on the basis of studies conducted at Semler.
The findings from FDA and WHO inspections question the reliability of all data generated at Semler, including data used to support marketing authorisation applications in the EU. Therefore, medicines agencies from Denmark, Germany, the Netherlands, Spain and the United Kingdom have requested EMA to assess the impact of these findings on the benefit-risk balance of medicines authorised in the EU. They have also requested EMA to look at the impact on medicines which are currently being evaluated for authorisation and which rely on study data from the site.
The Agency will now determine which medicines are concerned and will review available data to see whether any action is needed to protect public health. EMA will communicate further as appropriate.
More information and documents regarding this procedure are available on the European Medicines Agency webpage under "Human medicines-Referrals".