Joint GCP Initiative Launched by EMEA and FDA

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:

  • Regular information exchange on GCP inspections and their results. This is meant to facilitate the planning of future inspections.
  • Joint GCP inspections through exchange of information, experiences and approaches and co-operation during conduct.
  • Interpretation of GCP requirements and exchange on the respective legislation in force and expectations on the part of the authorities.

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: leslie.ball@fda.hhs.gov).

Sources:

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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