EU gives fast access to urgent new medicines
Medicines intended to treat serious diseases, orphan medicines and products for emergency use can now be authorised for use for one year before they have been fully tested.
A European Regulation (PDF 50K), allowing conditional marketing authorisations
for up to one year at a time, came into effect on 2 April. Such authorisations
will be renewable
annually.
Conditional licences will be granted on request to companies that develop
medicines that meet one or more of the three needs above, provided that
the risk-benefit balance is positive, that further safety data will be
produced and that the product satisfies an otherwise unmet clinical need.
Conditional licensing was included in the recently introduced updated
European pharmaceutical legislation, but needed an EC
Regulation to bring it into effect (PJ 17 January 2004, p47).
EC vice-president Günter Verheugen said: “Our initiative can
make a real difference for patients suffering from life-threatening diseases
for which no treatment exists. The new authorisation procedure can only
be used under strict conditions so that safety is not endangered.” |
The
Pharmaceutical Journal
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