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..
Health care system
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.
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
Pharma-Regist Ltd., 1051 Budapest, Október 6. U. 7., Hungary
Phone +36. 1. 318. 7160 Fax +36. 1. 318. 8546
Web site:
CRO services provided in Hungary
Clinical trial authorisation and EC opinion, feasibility survey, site selection and set-up, on-site monitoring, national project management



Managing Director
Vera Ruda
Poland Czech Republic Slovakia Hungary Romania Bulgaria