Studies of phases II and III require an approval of the National Medicines Agency (NMA) and of the National Ethics Committee (NEC). Meetings of both bodies, NMA and NEC, take place almost in the same period and usually the regulatory process takes 30-40 days.

Phase IV studies require a notification to the NMA only and an approval either by the Local Ethics Committee (LEC) for mono-centre studies or by the NEC for multi-centre studies. The study may start at the earliest 2 weeks after having obtained the approval of the LEC or NEC, respectively, and 40 working days after having notified the NMA, if no objections arise.

No other institutions but those authorised by the Ministry of Health (MoH) are permitted to conduct clinical trials. At these sites, an LEC must exist.

Customs clearance for supply shipment (single or multiple) is granted separately to the applicant by the MoH within a few days.

International standard patient insurance is fully acknowledged.

Overall approval time is approx. 40 days for phases II to IV.

Health care system

Almost all specialists are working in hospitals and in their private offices at the same time. Therefore, outpatients could be recruited from both sites, in case of a GCP-compliant site set-up. Complex examinations could be performed in hospitals and patients followed-up at private offices by the same doctors.

All major hospitals run their own well-equipped laboratory, GLP-certified by the NMA.

Infrastructure

Communication facilities comparable to Western Europe.

Large country, few highways only but good standards of road connections between major towns, good inter-city train network available, national flights between all major cities at reasonable prices.

Local office/staff

National affiliate branch office located in Brasov (Kronstadt), located in the centre of the country, 2.5 –3 hrs. by car/train from Bucharest’s international airport.

ECRON – SMP Clinical Development Ltd., Rahovei street no.7, 500182 Brasov, Romania
Phone: +40 268 42 54 83 Fax: +40 268 42 21 32
Email: bd@ecronacunova.com
or contact SMP Clinical Development for further specialized service

Links

EU enlargement pages
Authority: National Medicines Agency
Drugs registered in Romania, user name "ecron" and password "ecron"