The regulatory process takes 60 days for phase I to III, 30 days for phase IV (period legally limited) including an ethical evaluation. The extent of pharmaceutical data to be submitted (IMP dossier) depends on registration status of the trial drug in the EU and complies with the requests of the EU Clinical Trials Directive.

Customs clearance is granted to the applicant along with the approval, for single or multiple shipment(s) of the total supplies.

Concerning approval by Ethics Committees (ECs), the EU Directive has been fully implemented: The study has to be submitted to one Multicentre EC, approval period limited to 45 days. Study sites have to be approved by the competent Local ECs after having obtained the favourable opinion of the MEC, taking another 15 days. LECs mustn't comment on the project once it has been approved by the MEC but may disagree with the site's participation.

The Clinical Trials Directive has been fully implemented during May 2004. The State Institute for Drug Control (SUKL) offers consultation before the clinical trial application is submitted. However, up to now no estimate of the respective time lines can be made.

Overall approval time is about 60 days for phases I to III, 30 days for phase IV.

Health care system

Out-patients are treated in out-patient departments of hospitals or in single or group practices. Initial care by family doctor. In-patients are taken care for in national University hospitals or private clinics. Depending on specialisation, the degree of privatisation ranges from 20% to 80%. About 75% of the people are members of the General Health Insurance Fund.

Infrastructure

Communication facilities are comparable to Western Europe.

The highway cuts the country diagonally and provides a fast access to all major towns, no fast inter-city train system available, distances too short for national flights.

Local office/staff

ECRON - The Czech Expert s.r.o., Terronská 49, 16000 Prague 6,
Czech Republic
Email: bd@ecronacunova.com

Links

Official EU enlargement pages
Authority: State Institute for Drug Control "SUKL"
Drugs registered, enter the trade name in the 3rd field.