Tip:
Highlight text to annotate it
X
I'm Gerald Dal Pan and I am the acting Director of
the Center for Drug Evaluation and Research,
Office of Surveillance and Epidemiology,
the office at FDA that monitors the safety of
marketed drugs and therapeutic biologics.
Today, I want to talk about FDA's transformation
to a global agency.
The medicines we use are increasingly coming from
overseas.
In the US, this is 40% of finished drugs,
and 80% of their active ingredients!
What this means is that FDA is increasingly having
to think, act, and engage globally.
It has already begun to do this,
through initiatives like putting foreign posts in
key locations such as China and India,
harmonizing standards with other countries,
and doing more risk based monitoring and inspection
abroad.
It has also been involved in strengthening
regulatory capacity.
There are a number of examples of this,
but one is a recent meeting that FDA and the
US Agency for International Development
made possible in Nairobi, Kenya,
to convene a forum of African regulators on the
tools and best practices needed for conducting drug
safety activities.
By strengthening capacity in these systems,
we make sure that the anti-*** and other
infectious disease drugs provided through global
health programs, like the US Global Health
Initiative, are monitored for safety.
And, we also move closer to the commissioner's
vision of a global product safety net.
To learn more about FDA's global engagement
activities look for our recently released report,
Global Engagement, on the FDA website.
And to learn more about FDA's strategy for future
global engagement, search for the report,
Pathway to Global Product Safety and Quality.