“Despite the snowstorm that greeted me after my arrival, I have received a very warm welcome from FDA,” Boone began. Boone provided background about EMA’s current initiatives and its 2015 road map, as well as its new “corporate identity”: “We wanted to create a visual identity that better reflects what the agency is doing,” she said. EMA is in the process of revamping its website (making it more user friendly) and its interaction with the public. It has a new logo and, symbolically, has moved away from using its previous EMEA acronym.
One of its modes of outreach is connecting better with the U.S. FDA. There has been increasing collaboration between the two agencies, since bilateral meetings and confidentiality arrangements made earlier in this decade, Boone noted. The confidentiality agreements allow the two agencies to exchange draft guidelines, non-public inspection reports, training and education, and host workshops of mutual interest. Staff exchanges are also being facilitated.
Boone outlined the key areas of current collaboration between EMA and FDA:
Pediatric medicine: The agencies have a formal plan to exchange information on safety issues in children, and to explore convergence on submission formats. The aim is to have more of a global development plan for drugs to meet the needs of children, and ensure that they are not being exploited in clinical trials, Boone said.
Biomarkers and pharmacogenomics: the agencies have been hosting voluntary genomic data submission briefing meetings, among other activities. These are such new areas of research and growth, Boone said, that it’s critical that FDA and EMA coordinate their learnings and activities.
Parallel FDA-EMA Scientific Advice: This is a voluntary program, at the request of a drug’s sponsor, but has been working well thus far, Boone said. It has increased dialogue between the sponsors and agencies, and optimized development activities that meet both agencies’ requirements.
Product evaluation and surveillance: Boone noted that there are topic “clusters”—e.g., vaccines, oncology, advanced therapies—that are being discussed regularly through FDA-EMA video- and teleconferences. This is a mechanism for the agencies to be aware of each other’s ongoing product evaluations, and to provide a fast, regular exchange of views.
Product manufacturing and compliance: There are two ongoing projects in this regard. One is the conducting of joint inspections of manufacturing sites in the U.S. and EU. Another pilot project is collaboration on inspections of API in third countries. Australia and Canada are also participating in this latter project. The aim of course is for the agencies involved to save on resources and decrease the amount of duplicate inspections. “It really helps us to save resources, and probably cover many more sites than each of us could do on our own, so we can really have a risk-based approach on how we plan for our inspections,” Boone said.
“The success of all [these projects] is based on mutual confidence,” Boone concluded. “There is really a willingness and commitment within both parties . . . we hope it will foster a culture of convergence” between FDA and EMA.
--Paul Thomas
