A bilateral initiative aimed at maximising resources for Good Clinical Practice (GCP) inspections has been announced by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA).

The EMEA described the initiative as an important step towards building “a global regulatory network for the supervision of clinical trials”, while the FDA said it should ensure trials submitted as part of marketing approval applications for medicines in the US and Europe were conducted “uniformly, appropriately and ethically”.

The initiative, which will include information-sharing and collaborative GCP inspections of clinical trial sites and studies for products regulated by the EMEA and the FDA’s Center for Drug Evaluation and Research, will start with an 18-month pilot phase on 1 September 2009.

Among the key objectives are periodic exchanges of GCP-related information in order to:

- Streamline information-sharing relevant to GCP inspection planning, so that the selection of trials and sites for inspection is properly informed and inspection coverage improved
- Share GCP-related information in applications for scientific advice, orphan drug status, paediatric investigation plans, and marketing authorisation or post-authorisation activities of significant public health interest

- Communicate in an effective and timely fashion on inspection outcomes (both negative and positive) and their potential impact, where the clinical trials and/or inspected sites/organisations are of common interest.

Other key goals include:

- Conducting collaborative GCP inspections to build mutual understanding of, and confidence in, the inspection processes used by the European Union/EMEA and the FDA; and to improve the effectiveness of inspections by sharing best-practice knowledge to enhance inspection techniques and processes

- Sharing information on the interpretation of Good Clinical Practice to keep the respective agencies informed of GCP-related legislation, regulatory guidance documents, position papers and policy documents, whether in draft or finalised form; and to identify and act on areas where greater convergence could be achieved to the benefit of the clinical research process.

Once the pilot phase has concluded, the EMEA and the FDA will conduct a joint assessment of the scheme and will amend the process and modify its scope as necessary.

The initiative is being pursued within the framework of the confidentiality arrangements between the European Commission, the EMEA and the FDA that were extended through an agreement signed in September 2005. The parties to these arrangements can exchange information as part of their regulatory processes.

Increasing globalisation

As the EMEA and the FDA pointed out, the increasing globalisation of clinical research, coupled with limited inspection resources, “means that only a sample of sites and clinical studies can be inspected”.

If regulators can work “in a collaborative and synergistic manner” when carrying out GCP inspections and can exchange relevant information, “then GCP inspection resources can be used more efficiently”, the agencies added. Sponsors can facilitate this process “by informing regulators in the US and the EU of a joint filing which can be co-ordinated in both regions”.

Dr Murray Lumpkin, the FDA’s deputy commissioner for international programs, commented: “This is another initiative that will further the very robust relationship between the FDA and the EMEA. This will allow both the FDA and the EMEA to leverage each other’s GCP inspectional resources so both of us can use our resources to assure more of the clinical trials submitted to both agencies are of the highest quality.”