Regulatory and Ethics

Studies of phases II and III require an approval of the Romanian National Medicines Agency (ANM) 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 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, at the earliest 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.

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.


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 partner CRO

Partner CRO located in Brasov (Kronstadt), in the centre of the country, about 3 hrs. by car/train from Bucharestís intíl airport.

SMP Clinical Development Ltd.
Str. Calugareni no. 17, 500 182 Brasov, Romania
Phone/ fax: +40. 268. 42 44 4
Web site:

CRO services provided in Romania

Clinical trial authorisation and EC opinion, feasibility survey, site selection and set-up, on-site monitoring, project management 


Authority: National Medicines Agency
Drugs registered in RO, dalphabetical listing as pdf


Managing Director
Dionisie Czika
Poland Czech Republic Slovakia Hungary Romania Bulgaria