The Therapeutic Goods
Administration (TGA) and the
European Medicines Agency
(EMA) have agreed to share full
assessment reports for marketing
authorisation of orphan medicines.
The agreement was announced
at a meeting at the EMA office on
04 Apr by EMA executive director
Professor Guido Rasi and TGA
national manager Professor John
Skerritt.
If an application is received in
parallel by both regulators, they will
have the opportunity of scientific
exchange to help evaluation of the
medicine, the TGA said.
However, both would reach their
own conclusions as to authorisation
of the medicines.
The two agencies already
collaborate in other areas, including
a mutual recognition agreement on
good manufacturing practices for
medicines.
The new agreement would
reinforce collaboration and would
help accelerate access to new
medicines for patients with rare
diseases in both regions, the TGA
said.The above article was sent to subscribers in Pharmacy Daily's issue from 08 Apr 14 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 08 Apr 14
IN WESTERN Australia, Michael’s Chemist Group has started stocking therapeutic Nicotine Vaping Products (NVPs), pursuant to the Federal Government’s new vaping laws (PD 25 Mar).
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