THE European Medicines
Agency (EMA) has said the EU’s
decentralised system is being
used as a model to accelerate
assessment of generic medicines
applications in the International
Generic Drug Regulators Pilot
(IGDRP).
Australia is involved in the first
phase of this pilot project.
The decentralised procedure
meant assessment reports would
be shared in real time with
collaborating regulatory bodies
upon request from a generic
company, the EMA said.
Sharing assessments would
reinforce collaboration between
regulatory authorities globally and
should enable medicines to be
authorised in different areas in a
coordinated way at about the same
time, the EMA said.
New Zealand was a member of
the IGDRP and might decide to take
part at a later stage, the EMA said.
To read more, CLICK HERE.The above article was sent to subscribers in Pharmacy Daily's issue from 13 Aug 14 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 13 Aug 14
BREAST Cancer Network Australia (BCNA) has welcomed a PBAC recommendation to subsidise the breast cancer drug Enhertu (trastuzumab deruxtecan) for HER2-low metastatic breast cancer on the PBS.
PHARMACY Connect (PC2024) has revealed that Olympian Peter Bol will be sharing his journey from adversity to athletic greatness at the conference in Sep in Sydney.
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).
FREE Pharmacy Daily subscription - never miss another story!
to top
Subscribe to Pharmacy Daily
Pharmacy Daily subscription confirmation
Thank you for signing up! Check your email inbox – you should shortly receive a message with a link which must be clicked to confirm your subscription.
Once you’ve done that you will begin receiving Pharmacy Daily as soon as the next issue is published.