Regulatory Collaboration / 21st Century Innovation

By Chris Slawecki
DIA Senior Copywriter

On Monday June 25, the DIA 48th Annual Meeting convened an unprecedented panel discussion among senior regulatory executives on Regulatory Collaboration / 21st Century Innovation: Views of the Heads of Health Canada, the European Medicines Agency, and the US FDA.

The Point of View from Health Canada was presented by Paul Glover, MBA, Assistant Deputy Minister, Health Products & Food Branch, Health Canada. Executive Director of the European Medicines Agency (EU, UK) Dr. Guido Rasi presented The Point of View from the EMA, and The Point of View from the FDA was presented by Dr. Margaret Hamburg, FDA Commissioner.

Dr. Yves Juillet, Immediate Past President of the DIA Board of Directors, introduced this discussion by noting how it exemplified the “neutral, global forum” that DIA provides to industry, regulatory, and other thought leaders, to help advance safe and effective medicines all around the world. Each executive made introductory and concluding remarks; in between, they responded to questions from the audience.

Mr. Glover began by explaining the two foundational theses, and three basic priorities, for Health Canada: These theses are to remain true to the evidence as a science-based organization, and to become more transparent in operating upon that premise. Its priorities are to employ the brightest minds to keep up with changes in science and industry; operational excellence; and regulatory modernization, which he further broke down into two aspects, proportional oversight and moving from being a domestic to an international agency.

Dr. Rasi began by noting that the challenges he and Mr. Glover face are substantially the same. He summarized his view of regulatory collaboration in two key words: Trust and role. “Trust each other as regulators” is essential in our modern global environment, he explained. “The second aspect of trust is, frankly, the decline of trust in the pharmaceutical industries and in regulators,” he continued.

What is the role of the EMA? “Are we the gatekeeper, or are we the enabler? We are both,” he suggested. “If we address these two words – trust and role – I believe that we can move forward.”

“We share a common goal throughout our work: Trying to advance the work of human health and safety,” began Dr. Hamburg. These agencies also face the same economic restraints, operate in political systems, and deal with global products from complicated and geographically dispersed supply chains. “Clearly, we need to create a broader integration of global regulatory activities,” she said. Dr. Hamburg proposed the term “partnership” as an essential complement to Dr. Rasi’s concepts of trust and role.

After responding to several audience questions about drug shortages and other current topics, the three panelists shared closing thoughts.

Dr. Rasi referred back to the importance of his keywords: Trust, role, and (now) partnership. “The only way we can succeed in science is to be more international,” suggested Mr. Glover. “The only way we can be more transparent is to work more collaboratively with our stakeholders.”

Dr. Hamburg stressed the importance of streamlining and modernizing regulatory science, which brings together many supporting sciences (statistics, chemistry, etc.) and assembles them to support final regulatory judgment. “In the interests of our own mission, we need to create a much more explicit framework for collaboration with our global partners,” she concluded.

This session was co-chaired by Marie A. Dray (President, International Regulatory Affairs Group LLC) and Dr. Murray M. Lumpkin (Commissioner’s Senior Advisor and Representative for Global Issues, Immediate OC, FDA).
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