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Approval for
the conduct of a clinical trial has to be obtained from an Ethics
Committee. The principles of the Declaration of Helsinki must be observed.
Furthermore, the Spanish Medicines Agency is responsible for evaluating
and approving clinical trials before they can begin.
Clinical trials conducted for new dosages of medicines already registered
in Spain or for conditions other than those for which they are authorised
do not require an express approval from the Spanish Medicines Agency.
Approval is considered to have been granted if no negative response
is received within 60 days.
For all other clinical trials, however, explicit regulatory approval
is a precondition for commencing the trial. If no response is received
within 60 days, it has to be assumed that approval of the trial will
not be granted.
Upon receipt of an application for the conduct of a clinical trial,
the EC has 10 days to verify that the clinical trial meets all legal
prerequisites. Once this is done, it is to convey a favourable opinion
to the sponsor and to the Spanish Agency of Medication and Sanitary
Products within 60 days.
During these 60 days, the EC may but once ask for further information
from the sponsor. In this case, the counting of the 60 days time frame
would have to be suspended until the requested information has been
received by the EC.
For clinical trials with medication for gene therapy, somatic cell
therapy or for genetic engineering, the EC has a maximum of 90 days
to accord its approval or disapproval for an application. This time-limit
may be extended by another 90 days.
The EU Clinical Trials Directive 2001/20/EC has been implemented by
amending the Spanish Drug Act (Real Decreto 223/2004) on 6 February
2004.
 Local
office/staff
ECRON Spain, S.L., c/ Mejía Lequerica 22-24, bajos, 08028 Barcelona,
Spain
Email: bd@ecronacunova.com
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SPAIN
