Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

European Union Article 31 referral procedures: a case study on the example of GVK Biosciences

Stephan Hurtmanns (Abschlußjahr: 2015)

Summary
In May 2014, the Indian company GVK Biosciences Private Limited, one of Asia´s leading Contract Research Organizations, was inspected by the British (MHRA) and French Competent Authority (ANSM) for its GCP-compliance. Some findings reported by the French auditors during this inspection raised concerns on the reliability of the clinical part of bioequivalence studies conducted between 2008 and 2014 at the inspected site and the compliance with Good Clinical Practices (GCP). The affected BE-studies had been included into the dossiers of a large number of medicinal products authorized within the European Union.
A referral procedure under article 31 of Directive 2001/83/EC had been started in September 2014 and the European Commission has finally decided about a MA suspension of some medicines in July 2015.
Starting with the investigation of falsified ECGs submitted in Marketing Authorization Applications in France, the procedure has been extended to all medicinal products which had been authorized on the basis of bioequivalence studies conducted at the GVK Bio Hyderabad clinic. The investigation of falsified ECG data turned into an investigation of the overall quality system and the reliability of all information generated by the CRO.
Overall, the referral procedure raised a lot of questions and showed the difficulties to achieve a scientifically valid and accepted solution due to the fact that not the conducted BE-studies itself, but the ECG data generated subsequently to the studies have been assessed during the audit. Based on the assumption that falsification of ECG data also raises concerns on the overall quality assurance system, all BE-study data generated at GVK Bio Hyderabad site have been considered as inappropriate to support the benefit of the concerned generic products. Consequently, more than 700 MAs have been suspended in Europe in August 2015.
Pages: 35