With the key target of ensuring appropriate clinical trials, EMEA and FDA have launched a joint initiative. One goal is the further harmonisation of clinical trials for obtaining marketing authorisations in Europe and the USA as well as an overall reduction in time and costs of inspections for the authorities.
The initiative is to begin with a pilot phase on 1 September 2009. During the 18 months of this phase, the focus will primarily be on joint inspections of studies and clinical trial sites.
The key objectives are:
After the pilot phase, the process and the scope of the joint initiative are planned to be further adapted after an evaluation of the results and the experience gained.
Pharmaceutical enterprises that would like to participate in the joint inspections during the pilot phase can contact EMEA or FDA directly (Dr Ana Rodriguez, Inspections Sector: GCP@emea.europa.eu or Dr Leslie Ball, Director, Division of Scientific Investigation, CDER: firstname.lastname@example.org).
On behalf of the European Compliance Academy (ECA)