FEATURE
Features
The Geography of
Drug Approvals
How can
regulators
look at the
same data and
get different
results?
ASHClinicalNews.org
The goal of regulatory bodies such as the U.S. Food
and Drug Administration (FDA), the European
Medicines Agency (EMA), and the African Medi-
cines Agency is always the same: Balance potential
benefits and risks to ensure that the drugs that make
it to market are both safe and effective for patients
in need. Still, a drug that gains FDA approval may
give pause to European reviewers, despite having
reviewed the same evidence as their American coun-
terparts, and vice versa.
These contrasting conclusions are, in part, due to
each agency’s basic structure and processes: Both the
FDA and the EMA have distinct interactions with
external stakeholders, different methods of endpoint
evaluation, and individual comfort levels with risk.
ASH Clinical News spoke with representatives
from each agency, as well as independent investiga-
tors, to learn how the agencies make their decisions.
The Road to Approval
The road to approval is well-trodden: Once an
advanced phase trial (or even an earlier phase
study, through accelerated approval mechanisms)
is completed and shows encouraging results, the
company attempts to secure approval from the
relevant regulatory bodies for the drug to enter the
market.
In the U.S., that means submitting a new drug
application to the FDA’s Center for Drug Evaluation
and Research – one of the FDA’s largest centers. The
agency then has 60 days to decide whether the appli-
cation should be filed for review. 1 Filed applications
are then reviewed by a team of physicians , statisti-
cians, chemists, and pharmacologists, who assess the
data to determine the drug’s safety and efficacy for
the proposed indication.
Though FDA review is a strict, arduous process,
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