Module 6

04/10/2024

Examples of Issues

21 May 2015

EMA bans hundreds of drugs

over clinical trial studies

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

7

GVK Biosciences

• In 2015, the European Medicines Agency (EMA) recommended the suspension of over 700 medicines that were authorised based on clinical studies conducted by GVK Biosciences, a contract research organisation in Hyderabad, India. • The EMA’s decision was based on concerns about the integrity of the clinical trial data provided by GVK Biosciences. An inspection revealed systematic issues with the way the studies were conducted, leading to doubts about the reliability of the data. As a result, the EMA recommended suspending the marketing authorisations of these medicines until reliable data could be provided. • Highlighting the importance of rigorous oversight and quality assurance in clinical trials to ensure the safety and efficacy of medicines available in the European market.

The Organisation for Professionals in Regulatory Affairs

8

4