DruG DiscovEry & DEvELoPMEnT 9
Re-use of technology lies at the
heart of business expansion
As western pharma firms
A
s one door closes, businesses must operations, while making it very easy to adapt
look for their next opening. Today, these for other markets. This then gives them
look to distant waters the traditional strongholds of the maximum payback on their IT investment, too.
to land their next big
pharmaceutical industry, the US and If the regulatory submissions process was
opportunities, success
Europe, are witnessing a downturn in growth to onerous before, it has appeared even more so
will depenπd on efficient
around six per cent a year. This is the result not since the introduction of the Common Technical
re-use of technology,
particularly where
only of problems in the broader economy, but Document (CTD) and its electronic version (which
electronic submissions
also the loss of marketing exclusivity by products includes an XML backbone) called the electronic
are concerned. Kate
in a number of major therapeutic categories; Common Technical Document (eCTD). This
Wilber explains.
lower contributions from new products because standard is gradually becoming the preferred
of increased scrutiny of their value; and slower format for electronic submissions in key markets
take-up by doctors and healthcare systems. around the world as the global industry attempts to
Tandis que les
This is causing life sciences organisations sharpen up and harmonise on the formats, making
compagnies
to look to emerging markets which currently it possible to share and reuse data and thereby
pharmaceutiques
boast higher (double-digit) growth rates, simplifying submissions to multiple regulators.
occidentales tournent
leur regard vers des
such as China, India, Brazil, Russia, Mexico, Although these changes may appear to create
rivages lointains pour y
Turkey and South Korea, to supplement their another administrative burden for companies,
➠
établir leurs prochaines
existing revenue streams. But
grosses opportunités, targeting new markets presents
leur succès dépendra a challenge. Each country varies
d’un réemploi efficace
in its regulatory requirements,
de la technologie, en
multiplying the administration
particulier lorsqu’il s’agit
hurdles organisations have to jump
du dépôt électronique
des demandes. Les
to prepare licence submissions.
explications de Kate
The risk is time to market – firms
Wilber.
looking to break into new markets
need to be ahead of the game if
they want to gain early ground over
Der Erfolg westlicher
their rivals.
Pharmaunternehmen,
The growing standardisation
die in die Ferne ziehen,
of regulations around the world
um ihre nächsten
should help in the long term,
großen Gelegenheiten
zu verwirklichen, hängt
making it easier for organisations
von der effizienten
to play across multiple markets
Wiederverwendung
without sending their costs out
der Technologie of control, but as each region
ab – insbesondere responds to global standards at its
bei elektronischen
own pace, the current disparity has
Einreichungen. Mehr
the potential to create a lot of extra
darüber von Kate Wilber.
work for regulatory operations
managers and their colleagues.
Maximising ROI
The answer, many firms are
discovering, is to identify technology
solutions that give them a dual
advantage – helping them to address
domestic changes in submissions
practices and at the same time
giving them lots of productivity and Fig. 1. From a quiet start, the number of eCTD transactions is
cost-efficiency gains in their own expanding rapidly.
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