 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.
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 partner CRO
Partner CRO located in Brasov (Kronstadt), in the centre of the
country, about 3 hrs. by car/train from Bucharest’s int’l airport.
SMP Clinical Development Ltd.
Str. Calugareni no. 17, 500 182 Brasov, Romania
Phone/ fax: +40. 268. 42 44 4
Email: romania@phamos.cz
Web site: www.smp.ro
CRO
services provided in Romania
Clinical trial authorisation and EC opinion, feasibility survey,
site selection and set-up, on-site monitoring, project management
Links
Authority: National
Medicines Agency
Drugs
registered in RO, direct access to listing with search function
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