Clinical research in Moldova

Part of Romania during the interwar period, Moldova was incorporated into the Soviet Union at the close of World War II. With tight cultural and linguistic relations to Romania, the country becomes independent from the USSR in 1991.

Population: 3,560,430 (estimate 2011)

Main regulatory procedures

Clinical trial authorization

Purposes of clinical research in Moldova are reflected in the classification of clinical studies.

The competent authority responsible for approval and supervision of clinical studies is the Drug Agency within the Ministry of Health and Social Protection (hereinafter referred to as the Drug Agency).

The study approval procedure consists of the following steps:

Study MD

Customs regulations of IMP and human biological material

Import permission for non-authorized medicinal products for the purpose of clinical research is issued by the Drug Agency. Documents required for submission include study approval, information on the IMP (quality documentation, manufacturer), and CTP synopsis.

Export requirements for human biological material for the purpose of clinical research have not been identified in the reviewed legislation. The law No. 1456-XII states that written agreement from the patient is required for sampling, storage and use of all types of biological material. Written agreement is also required when the biological material is used for diagnosis or treatment of disease.

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