(Saint Petersburg, FL - August 22, 2011)

The U.S. Food and Drug Administration (FDA), in conjunction with its counterparts in Europe and Australia, has released two reports that recap pilot programs that were launched to enhance international regulatory collaboration and help to ensure drug quality and safety on a global level. The following are the two focus areas discussed in detail:

Good Clinical Practice (GCP): This report discusses information-sharing and collaboration on inspections relating to clinical trials. The report lays the foundation for a more efficient use of limited resources, improves inspectional coverage, and provides a better understanding of each agency's inspection procedures. The report demonstrates how the agencies can work together to improve human subject protection and better ensure the integrity of data submitted as the basis for drug approvals.

Active Pharmaceutical Ingredients (API): This report discusses information-sharing among the FDA, Australia's Therapeutic Goods Administration (TGA) and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines and Healthcare (EDQM) relating to APIs. This report lays the foundation for decision making whether the agency should postpone or expedite its own inspection of an API facility. The report also details FDA's plans to prohibit imports into the U.S. of a firm's products based on negative findings from a European inspection.

According to Jonathan Lewis, Principal at Advanced Biomedical Consulting, a leading FDA compliance consulting firm, "it is certain that FDA will continue with this global strategy and partner with agencies worldwide to ensure global product safety and quality."

 (Saint Petersburg, FL - August 22, 2011)