A pair of pilot programs fostering increased cooperation among
health regulators in the US, EU and Australia have been declared
successes, paving the way for further international collaboration. The
US Food and Drug Administration (FDA), European Medicines Agency (EMA)
and Australia's Therapeutic Goods Administration worked together on a
pilot to jointly inspect active pharmaceutical ingredient (API)
manufacturers, while a second pilot between FDA and EMA focused on Good
Clinical Practice. FDA and EMA have already announced plans to continue
their collaboration. "It is imperative that FDA work closely with its
counterparts in order to ensure the safety and quality of products and
the integrity of clinical trials. We cannot do it alone," said Deborah
Autor, FDA deputy commissioner for global regulatory operations and
policy.
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