FDA and EMA Strive for Convergence on Path to Harmonization

June 24, 2015

The FDA and the European Medicines Agency are working to increase regulatory collaboration, including harmonizing their respective pharmacovigilance and quality by design programs, officials from both agencies said. 

The agencies meet monthly to discuss hot product issues, covering more than 70 since the collaboration started in 2013, Peter Arlett, head of pharmacovigilance for the EMA, said during a roundtable discussion at the DIA annual meeting in Washington, D.C.

They also warn each other about big safety or quality issues that could cause drug shortages.

Meanwhile, an EMA-FDA quality by design pilot was begun in March 2011 and will run through April 2016. Under that program, companies agree to share information with both agencies and then the two agencies conduct parallel reviews and share their findings.

So far one marketing authorization application with QbD elements has been completed, as well as joint consultations with nine drugmakers. The goal is to ensure consistent implementation of ICH guidelines Q8 through Q11, as well as ongoing EMA-FDA discussions on chemistry, manufacturing and controls topics.

The agencies have also published three ICH Q&A documents, said Christine Moore, acting director for process and facilities within the FDA’s Office of Pharmaceutical Quality.

A future goal is to harmonize labels on products, said Arlett, noting that labeling is something the agencies talk to each other about, but don’t currently collaborate on. There may soon be an opportunity to do so, however, as the EMA plans to revisit its labeling guidelines in the near future and will take that opportunity to discuss harmonization with the FDA, he said.

The agencies also plan to increase product-specific discussions and are talking more about the best use of mobile technology and social media for monitoring adverse events and communicating with stakeholders. — Kellen Owings