FDA Expands Pharma Quality Collaboration With EC And EMA

The Food and Drug Administration (FDA) announced in its blog, the FDA Voice, that it intends to deploy a team to work with the European Commission (EC) and the European Medicines Agency (EMA). The initiative expands on the existing collaboration in an attempt to regulate drugs on a global scale, which the FDA calls “a tall order.” The FDA team, along with its counterparts at the European agencies, will focus full-time on pharmaceutical quality. The federal agency states that it needs to deepen its reliance on regulators outside of the U.S. to provide safety and protection to Americans.

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy wrote, “As a public health regulatory agency with a global presence, we look forward to strengthening our mutual reliance and capitalizing on our shared interests.”

European Medicines Agency 

Last month, the European Medicines Agency (EMA) issued a press release informing the public about the recent meeting with the FDA. Senior leadership from the EC, the EMA, and the FDA met in London recently to discuss issues common to the three agencies. The EMA provided a summary of their successes and challenges.   

• Pharmacovigilance – the two agencies both acknowledge that the 2013 EMA/FDA pharmacovigilance program was successful, and both sides wish to continue the activity
• Substance registration – the agencies will explore the possibility of creating a substance registration software program and a task force called the EU-US Identification of Medicinal Products (IDMP)
• Drug supply chain – the two see a need for better information sharing and for better ways to leverage manufacturing inspection efforts

The EMA said that the meeting allowed new personnel at both agencies to meet each other and explore issues common to both. Senior meetings usually take place every eighteen months and provide regulators an opportunity to strategize beyond the scope of the work-sharing interactions between the FDA and the EC/EMA, which average under 100 per month.

Presumably, with the new expanded collaboration, the number of work-sharing meetings will increase to over 100 per month, and senior leadership will meet more often, but neither agency provided details on meeting frequency. The FDA did indicate the personnel they would dedicate to the new team, including experts from

The Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Office of Global Regulatory Operations and Policy.