“Through this initiative, and in cooperation with the European Commission (EC) and the European Medicines Agency (EMA), FDA will aim to deepen our reliance on trusted regulators outside of the US who provide equivalent public safety and quality protection,” Howard Sklamberg, FDA’s deputy commissioner for global regulatory operations, wrote in a blog post earlier this week.
Although details on how this project will differ or add to existing collaborations between the two regulatory bodies are scant, FDA spokesman Stephen King told In-Pharmatechnologist: “There are meetings being held over the next week or so and they have let me know that we will be putting together additional information that we can share following those meetings.”
According to an email obtained by RAPS, the new initiative will be led by Dara Corrigan, former associate commissioner for regulatory affairs.
“We now have more than 60 agreements with foreign counterparts to share certain information in inspection reports and other non-public information that can help us make better decisions about the safety of foreign products,” Sklamberg writes.
In addition to this latest initiative, the agency in recent months has stepped its desire to tackle quality issues with the creation of a new “super-office” that will deal with all things quality related.
That office, a $20m effort to inspect more generic products, and the desire to add more inspectors in India, which produces a disproportionate amount of the world’s drug ingredients, will all add to the FDA’s ramp-up of quality control efforts.
The new initiative “is the latest step in our continuing efforts to improve the quality of pharmaceutical products – a step that will deploy a dedicated FDA team to work with our European counterparts on a host of issues. The team, which will focus full time on pharmaceutical quality, will include experts from our Center for Biologics Evaluation and Research, our Center for Drug Evaluation and Research, and our Office of Global Regulatory Operations and Policy,” Sklamberg wrote.