US Food and Drug Administration and European Medicines Agency Launch Good Clinical Practices Initiative

Abstract

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) announced an agreement on August 3, 2009, to launch a bilateral Good Clinical Practices (GCP) initiative. The initiative is designed to ensure that clinical trials submitted in drug marketing applications in the United States and Europe are conducted “uniformly, appropriately and ethically.”In most cases, the same clinical trials are used to support Marketing Authorisation Applications to the EMEA, and New Drug Applications and Biologics License Applications to the FDA. Having begun with an 18-month pilot phase on September 1, 2008, this initiative will involve products regulated by the FDA's Center for Drug Evaluation and Research in the United States, and by the EMEA for the European Union.“Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health,” said Commissioner of Food and Drugs Margaret A. Hamburg, MD, in a prepared statement. “This important effort will help to strengthen safeguards for participants and others involved in clinical studies.”Key objectives of the FDA–EMEA GCP initiative will be to:•Conduct periodic exchanges for GCP-related information to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes;•Conduct collaborative GCP inspections by sharing information, experience, and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge; and•Share information on the interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.At the conclusion of the pilot phase, a joint assessment will be made by the FDA and the EMEA, with the scope and process modified and amended as needed. The agencies are seeking to partner with applicants/sponsors who are willing to volunteer during the pilot phase of the initiative to engage in dialogue and planning of joint inspections involving applications that are anticipated to be submitted fairly simultaneously to both regulatory agencies within the next 12 months.The FDA says the increasing globalization of clinical research, coupled with limited inspection resources, means that only a fraction of clinical research sites can be inspected. It is thought that if regulators can work in a collaborative and synergistic manner in carrying out GCP inspections and implement information exchanges, then GCP inspection resources can be used more efficiently. Sponsors can also facilitate this process by informing regulators in the United States and the European Union of a joint filing, which can be coordinated in both regions. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) announced an agreement on August 3, 2009, to launch a bilateral Good Clinical Practices (GCP) initiative. The initiative is designed to ensure that clinical trials submitted in drug marketing applications in the United States and Europe are conducted “uniformly, appropriately and ethically.” In most cases, the same clinical trials are used to support Marketing Authorisation Applications to the EMEA, and New Drug Applications and Biologics License Applications to the FDA. Having begun with an 18-month pilot phase on September 1, 2008, this initiative will involve products regulated by the FDA's Center for Drug Evaluation and Research in the United States, and by the EMEA for the European Union. “Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health,” said Commissioner of Food and Drugs Margaret A. Hamburg, MD, in a prepared statement. “This important effort will help to strengthen safeguards for participants and others involved in clinical studies.” Key objectives of the FDA–EMEA GCP initiative will be to:•Conduct periodic exchanges for GCP-related information to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes;•Conduct collaborative GCP inspections by sharing information, experience, and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge; and•Share information on the interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process. At the conclusion of the pilot phase, a joint assessment will be made by the FDA and the EMEA, with the scope and process modified and amended as needed. The agencies are seeking to partner with applicants/sponsors who are willing to volunteer during the pilot phase of the initiative to engage in dialogue and planning of joint inspections involving applications that are anticipated to be submitted fairly simultaneously to both regulatory agencies within the next 12 months. The FDA says the increasing globalization of clinical research, coupled with limited inspection resources, means that only a fraction of clinical research sites can be inspected. It is thought that if regulators can work in a collaborative and synergistic manner in carrying out GCP inspections and implement information exchanges, then GCP inspection resources can be used more efficiently. Sponsors can also facilitate this process by informing regulators in the United States and the European Union of a joint filing, which can be coordinated in both regions.