Collaboration between the 2 of the world’s premier pharmaceutical regulatory bodies (FDA and EMEA) has increased markedly in the last few years, a process which has come largely in response to the rapid globalization of drug development, manufacturing, and production. Distillation of an interview with Murray Lumpkin, the FDA’s Deputy Commissioner for International Programs who is spearheading the FDA’s efforts in this field, gave several succinct insights relative to the history and context of the collaboration and drug safety (preclinical and clinical) initiatives, among others.
Over the past 10-15 years, the FDA and EMEA initially focused on understanding each other’s regulatory systems. This initiative evolved to sharing information (managerial and technical) since pharmaceutical companies were submitting largely similar information to both Agencies. The “Transatlantic Administrative Simplification Action Plan,” a centerpiece of this relationship, covers 4 primary areas of potential convergence: 1) quality and inspections, 2) pharmacovigilance, 3) scientific collaboration, and 4) guidelines, format harmonization, and electronic submission. Information is shared about applications, questions and answers, and pre-decisional information. Drafts of guidance and policy documents are also shared prior to publication. We try to give each other a heads up on newsworthy items and/or something that is likely to generate questions for them. We don’t want to blindside each other, particularly in regard to issues with a public health or safety impact. This cooperation has led to the permanent placement of an executive in each other’s organization: Janice Soreth (from FDA) and Hilde Boone (from EMEA).
FDA/EMEA “clusters” in pediatrics and oncology have been particularly active, with periodic teleconferences detailing current applications and upcoming actions, challenges and difficult questions, and various meeting updates (sometimes with joint participation). Although resolutions may differ between Agencies, there is a mutual understanding of how decisions were formulated, and an acknowledgment that similar data was evaluated by both. Other examples of joint clusters include: vaccines, pharmacogenomics, orphan medicines, and cardiovascular.
The potential for joint acceptance of each other’s drug approvals was discussed. It was acknowledged that although regulatory decisions are largely science based, there are also jurisdictional componenets, such as risk tolerance, which remain largely cultural. For this reason, mutual acceptance of drug approvals was not seen as likely in the near term.
Upcoming prospects for convergence may involve leveraging each other’s resources (e.g., GMP and GCP inspections) to reduce audit duplication. The distinction was made that this effort would enable the Agencies to rely on each other’s information, but not necessarily on each other’s decisions. Other areas of possible harmonization may include biomarkers (e.g., the recent joint validation of renal toxicity biomarkers), as well as trial design and comparators. In regard to drug safety, the pharmaceutical industry has been invited to conduct a study to compare the EU and US approaches to risk management formats (e.g., E2E, Volume 9a RMP Guidance, REMS, etc.) and to identify opportunities for convergence. In addition, other areas for possible convergence were discussed.