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A View From the Top

What were the main challenges you faced as a result of globalization?

Finding out just how much of our food and medicine either comes from overseas, or is composed of elements from overseas, was a revelation. We needed to find a way of ensuring the quality of the products coming in, as well as the integrity of the supply chain. In the past, goods could be checked for quality at the border, but, with the dramatic increase in volumes, that just isn’t practical today. We had to oversee an increasing number of players in a complex supply chain, with many products coming from countries where the regulatory infrastructure is much less mature than in the US or the EU.

How did you go about tackling the problem?

The scale of the problem and the workload involved was enormous. There were literally tens of thousands of facilities that we needed to inspect; in an era of constrained resources, and with new increasingly complex products, it was a challenge that required new solutions. The first thing we had to do was become much more global in terms of our reach, which meant increasing the number of FDA offices worldwide and building our capacity to do site inspections overseas – working with companies and other regulatory authorities.

How important was collaboration?

Well, we weren’t the only agency faced with this problem. Countries across the developed world were thinking about how to deal with globalization and products coming from a wide range of countries. Building bilateral relationships with those countries – sharing information more effectively – was important. We needed to think about how to better harmonize systems of inspections and approaches to approvals so that different regulatory agencies could share workloads. It seemed crazy to me that you could have FDA inspectors going into a plant, followed by EMA inspectors, followed by Health Canada, and so on. And yet other facilities would go unvisited for prolonged periods of time.

Our aim was to find ways to pool our resources to work better as regulators, and to also decrease unnecessary burdens on companies that have to deal with different serial inspections, each with different requirements and expectations.

Working within systems of international collaboration was also very important: the ICH and WHO being two examples, as well as the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which we joined while I was commissioner. It was clear to me that we had to approach global collaboration in a much more organized way, so we began building on some of the initiatives that were already in place, as well as trying to extend and clarify those activities.

We also undertook an effort to create an umbrella organization, the International Coalition of Medicines Regulatory Authorities (ICMRA), to oversee/coordinate the activities of the ICH, PIC/S and some of the other initiatives, to make sure we were covering the necessary landscape and that there wasn’t duplication of efforts. There were critical issues that needed to be addressed, such as information sharing and the question of how to align different national regulatory authorities when every country has their own national laws and standards. Greater integration and more information flow is key to allowing national regulatory authorities to do their jobs in a globalized world.

You can read more from Margaret Hamburg in the November issue of The Medicine Maker.

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