US FDA to launch new supply chain initiative with EU counterparts

By Zachary Brennan

- Last updated on GMT

US FDA to launch new supply chain initiative with EU counterparts
As the worldwide pharma supply chain gets even more complex, the US FDA is looking to leverage its existing relationship with its EMA (European Medicines Agency) counterparts to boost drug quality with a new initiative.

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.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

Follow us

Products

View more

Webinars