First, the National Institute of Pharmacy (NIP, Hungarian: OGYI) will review the trial. Provided that the Clinical Pharmacology Ethics Committee (CPEC) of the Medical Science Council has granted its favourable opinion, the NIP will approve the trial.

The regulatory process is limited by law to 60 days. Any request for more information may prolong the approval process.

The Local Ethics Committee (LEC) procedure can be applied for after the regulatory approval 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.

Phase I-II trials can only be conducted by investigators/sites acknowledged by the NIP.

There is no different procedure for trials of phases II - IV.

International standard patient insurance is fully acknowledged.

Customs clearance is not issued automatically with the approval, but is granted upon request.

Health care system

The law about the privatisation of the 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 office/staff

ECRON Pharma-Regist Ltd., 1051 Budapest, Október 6. U. 7., Hungary
Phone +36. 1. 318. 7160 Fax +36. 1. 318. 8546
Email: bd@ecronacunova.com

Links

EU enlargement pages

Authority: National Institute of Pharmacy (OGYI)
Drugs registered in HU