Pharmacy Daily | TGA works with EMA, FDA

WORLD regulatory
collaboration is one step
closer, following the successful
conclusion of two pilot programs
of collaboration on inspections
between the European
Medicines Agency, the United
States and Australia.
The aim of the programs was
to enhance global drug safety
and quality via increasing
international regulatory
collaboration.
The first pilot program saw
information sharing and
inspection collaboration during
trials, and saw the exchange of
more than 250 documents
relating to 54 different
medicines between the EMA
and FDA, as well as 13
collaborative inspections of
clinical trials.
“This lays the foundation for
a more efficient use of limited
resources, improved
inspectional coverage and
better understanding of each
agency’s inspection procedures,”
a statement from the EMA said.
The second trial revolved
around joint active
pharmaceutical ingredients
(API) inspections, and saw
authorities including the TGA,
FDA and EMA, as well as those
from France, Germany, Ireland,
Italy and the UK, collaborate
and share information on API
inspections.
The result of the second
program was the exchange of
nearly 100 inspection reports,
as well as nine joint
inspections.
“Based on the positive
experience in the two pilots,
the agencies have agreed to
continue with their
collaboration on inspections,
taking into account the
experiences and lessons
learned during the pilot
phases,” the EMA said.