Regulatory Process: Romania, Moldova, Georgia

ARENSIA has the know-how to successfully manage the regulatory process in various Eastern European countries.

This is especially important for Phase 1/2 studies in patients which involve complex scientific/exploratory protocols and which - case by case – imply compensation schemes for the subjects.

In Romania the regulatory approval process takes 60 days (parallel review by Health Authority and Central Ethics Committee) and it follows the EU Clinical Trials Directive, Romania joined the EU in 2007. The set of documents required for submission in these countries is similar to the other countries in the European Union (all documents, except patient related documents - ICF, patient diaries - are submitted in English). 

In Moldova the regulatory approval process takes 30 days (parallel review by Health Authority and Central Ethics Committee). Moldova does not belong to the EU. The submission package is similar to the one in EU countries, with the exception that it does not require full IMPD package or CMC file. The main documents (such as IB, Protocol, etc) are submitted in English. The ICF language is Romanian, as the authorities accept Romanian language (which is official language in Moldova).  

In Georgia the regulatory approval process takes 35 days. Georgia does not belong to the EU. The review by the local EC takes 14 days, followed by review from Health Authority (Drug Agency), which takes further 20 days. No IMPD is required. Study protocol and patient related documents are submitted in Georgian language. IB is submitted in English.

 

Irrespective of the given project, we keep close contact with the regulatory bodies, as they request solid scientific data and thoroughly developed protocols.

 

 

Contact

ARENSIA Exploratory Medicine GmbH

Merowingerplatz 1
40225 Duesseldorf, Germany

Email: undefinedinfo(at)arensia-em.com

Office phone: +49 (211) 15 77 89 0
Office fax:      +49 (211) 15 77 89 10

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