The European Medicines Agency
has released a new draft scientific
guideline outlining how “postauthorisation
efficacy studies”
should be designed by companies
to support regulatory decision
making in the European Union.
The studies are conducted within
the authorised indication after
a medicine has been granted a
marketing authorisation, to collect
data on aspects of its benefits that
can only be explored once the
medicine is marketed.
See www.ema.europa.eu.The above article was sent to subscribers in Pharmacy Daily's issue from 10 Nov 15 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 10 Nov 15
NEW data from the Australian Institute of Health and Welfare has revealed around 43% (or 8.5 million) of Australians aged 16-85 have experienced a mental disorder at some point in their lives.
THE Pharmacy Guild of Australia has formally expressed its concerns regarding the potential merger between Sigma and Chemist Warehouse (PD 07 Dec 2023) to the Australian Competition and Consumer Commission (ACCC).
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