Th e Therapeutic Goods
Administration (TGA) has greeted
the pharmaceutical industry with
its planned changes to fees and
charges effective 01 Jan 2016.
Go to www.tga.gov.au for details.
In addition, the TGA is introducing
pilot changes to the pre-submission
phase of the prescription medicines
registration process.
The pilot commences 01 Feb
2016, is not compulsory and is
suited to all Type A (New Chemical
and New Biological Entities and
Biosimilars) and Type D (New
Generic Medicine) applications.
The pre-submission pilot will
evaluate the effectiveness of
removing the need to provide a
‘Module 2 or equivalent’ with Pre-submission
Planning forms (PPFs)
and should reduce the workload
for applicants and the overall
registration timeline by at least a
month, the TGA said.
Applicants are reminded that the
current registration pathway will
still be available.
Got to www.tga.gov.au for more.The above article was sent to subscribers in Pharmacy Daily's issue from 15 Dec 15 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 15 Dec 15
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