 Regulatory
and Ethics
The process of clinical trial authorisation by the competent
Hungarian authorities "National Institute of Pharmacy"
(NIP, Hungarian: OGYI) takes up to 60 days for all trial phases;
EMEA's request form is to be used.
Any objections or requests for completion may prolong the authorisation
process. The OGYI will
review the trial and, provided that the Clinical Pharmacology Ethics Committee
of the Medical Science Council has granted its favourable opinion,
will approve the trial.
The LEC procedure can be applied for after the clinical trial authorisation
has been obtained. The duration differs depending on the type of
LEC from 2 to 6 weeks, therefore the overall approval time ranges
from 2.5 to 4 months, exceeding in most cases the timelines of the
EU CT Directive..
The law on privatisation of hospitals has been set in force by the
Parliament in July 2003, so that the major part of outpatients could
still be found centrally in hospitals. For each investigational site,
a link to a hospital is required by law.
Infrastructure
Communication facilities comparable to Western Europe.
Inter-city train connection from Budapest to all major towns available,
distances too short for national flights, no highway connections
to major towns.
Local
partner CRO
CRO
services
provided in Hungary
Clinical trial authorisation and EC opinion, feasibility
survey, site
selection and set-up, on-site monitoring, national project
management
Links
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