TGA OTC approval times reined in
December 18, 2015
The Therapeutic Goods
Administration has in general terms
been able to reduce approval times
for OTC medicine applications in
the first half of this year compared
to 2014, with almost all application
types being completed within half
or less of target times, according to
the TGA’s half yearly performance
report Jan to Jun 2015.
No registered complementary
medicines applications were
rejected during the reporting
period, with one new medicine and
13 variations approved.
The report references TGA key
performance indicators around
approval times, submission
outcomes, orphan drug
designations, biological medicines,
generics, complementary
medicines, adverse event reports,
medical devices and more.
Export issues, special access
schemes, recalls as well as licensing
and manufacturing issues are also
summarised.
For full details see the report
online at www.tga.gov.au.
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