FDA & EMEA collaborate on GCPs
By collaborating the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) believe they will be better equipped to ensure trials are conducted in accordance with GCPs.
Margaret Hamburg, Commissioner of the FDA, explained: “Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health.
“This important effort will help to strengthen safeguards for participants and others involved in clinical studies.”
The increasingly globalised nature of clinical trials has put a strain on both regulatory agencies but the situation can be improved by applying the three broad objectives of the pilot programme.
Under the terms of the arrangement the agencies will conduct collaborative inspections. By doing this regulators hope to build mutual understanding and confidence in their respective inspection processes.
In addition the agencies will share experiences, information and best-practice knowledge relating to GCP inspections.
Lightening the load
Another objective that largely relates to inspections covers the exchange of GCP related information. One aspect of this aims to improve the exchange of information related to inspection planning to increase efficiency and broaden site coverage.
Furthermore, the outcomes of investigations into sites of common interest will be communicated effectively and in a timely manner between the EMEA and FDA.
GCP related information contained in applications, such as marketing authorisations, will also be exchanged between the agencies.
The final objective focuses on the sharing of information relating to interpreting GCP. This entails passing on news related to GCP legislations, guidance documents, policy papers or position papers.
In addition the agencies will identify areas where greater convergence is possible and could improve the clinical research process.
The pilot programme will start on September 1 and run for 18 months.
