FDA, international counterparts report progress on drug inspection collaboration

August 12, 2011

The results of pilot programs focused on increasing international regulatory collaboration among the agencies that aim to enhance drug quality and safety globally, have been released by FDA together with its European and Australian counterparts.

Progress has been made on increasing international regulatory collaboration among the agencies that aim to enhance drug quality and safety globally, according to the results of 2 pilot programs by FDA and its European and Australian counterparts.

The pilot programs are part of FDA's global strategy to ensure the safety and quality of imported products. According the agency’s statement, the number of foreign drug manufacturing inspections increased by 27% between 2007 and 2009 and the agency has opened several international offices in key locations such as China and India.

The Good Clinical Practice (GCP) initiative, launched in September 2009, was aimed at improving information sharing about inspections and GCP-related documents of common interest and collaboration on inspections relating to clinical trials.

The pilot, which concluded March 2011, addressed products submitted as New Drug Applications (NDAs) and Biologics License Applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER) and the same products submitted as marketing authorisation applications to the European Medicines Agency (EMA). More than 250 documents relating to 54 different drug products were exchanged and 13 collaborative inspections of clinical trials were organized, according to an agency statement.

“The thirteen collaborative inspections conducted under the initiative have contributed greatly to each agency’s understanding of the other’s inspection procedures; they have also led to the identification of potential improvements to these procedures,” according to the executive summary. “Both agencies have learned several general lessons during the process, while acknowledging that every inspection is unique and that there will always be some individual differences between inspectors.”

Next steps will include expanding the initiative to sites outside of the United States and European Union and focusing inspections on sponsors and CROs instead of investigator sites. The agency will also explore expanding the initiative to areas such as bioequivalence (BE) trials in generic applications and will also explore the possibility of expanding the initiative to FDA’s Center for Biologics Evaluation and Research (CBER).

The Active Pharmaceutical Ingredients initiative was conducted between December 2008 and December 2010 with the goal of fostering cooperation and mutual confidence through better communication and exchange of information on inspection planning among FDA, Australia's Therapeutic Goods Administration and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom, and European Directorate for the Quality of Medicines & Healthcare (EDQM), according to the executive summary in the final report.

The organizations shared their surveillance lists and found 97 sites common to all 3 regions, resulting in the exchange of nearly 100 inspection reports and in 9 collaborative inspections, the statement said. FDA used these reports to make informed decisions, such as whether to postpone or expedite its own inspection.

"It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone," said Deborah M. Autor, FDA deputy commissioner for Global Regulatory Operations and Policy in a press release. "We are grateful to our European and Australian colleagues for their willingness to partner with us in these pilot programs. The pilots are important stepping stones toward further global regulatory collaboration."

The report recommended extending the program to more comparable regulatory authorities and possibly the World Health Organization to develop an efficient worldwide program of inspections of APIs for the benefit of global public health.