Moldova

Regulatory

Although the Republic of Moldova is a comparatively small country, the development of clinical trials has recently grown dramatically. To perform a clinical trial in Moldova, the sponsor must obtain an approval from the Ministry of Health. The Regulatory Authority which is responsible for granting approvals is the Medicines and Medical Devices Agency, which was established in 2005 and is responsible for regulating the clinical trial field in Moldova. All clinical trials must also be approved by the Ethics Committee established in 2016. The sites must be accredited and comply with the national and GCP (Good Clinical Practice) standards. In order to import the investigational product, the sponsor must also receive a special approval.

Official links

https://amdm.gov.md/ro

Pharmaceutical Industry & Clinical Trials Market

In the last few years Republic of Moldova has aligned its legislation with the EU, securing the rights of patients and improving the quality of medications in the country. The most recent achievement is the transposition of the European Pharmacopoeia into the Moldovan law, which protects patients from adverse reactions caused by medical products.

Moldova’s current pharmacovigilance system is a well-developed mechanism, with several methods for ensuring that the medicines offered to Moldovan patients comply with the European safety requirements. By adhering to the Convention on the Elaboration of a European Pharmacopeia in 2016, Republic of Moldova undertook the responsibility to observe and comply with the standards and requirements established by the European Pharmacopoeia and to impose them on any drug manufactured in or imported into Republic of Moldova.

Medical System in Moldova

At present, the health system includes both public and private medical facilities. Public authorities are involved in providing, financing, regulating and administering health care services. In primary and secondary care, public medical facilities offer services to communities and are governed by local public authorities. All public medical facilities are independent, non-profit making organizations which are contracted by the National Health Insurance Company.