An in-depth analysis of pharmaceutical regulation in the Republic of Moldova

Alessandra Ferrario, Nina Sautenkova, Zinaida Bezverhni, Rita Seicas, Jarno Habicht, Panos Kanavos, Vladimir Safta

Regulation of the pharmaceutical system is a crucial, yet often neglected, component in ensuring access to safe and effective medicines. The aim of this study was to provide an in-depth analysis of the existing pharmaceutical regulation, including recent changes, in the Republic of Moldova. Data from field work conducted by the World Health Organization (WHO) together with a review of policy documents and quantitative secondary data analysis was used to achieve this aim. This analysis identified several ways in which pharmaceutical regulation affects availability of quality medicines in the Republic of Moldova. These include lack of full implementation bioequivalence requirements for generics registration, incomplete implementation of good manufacturing practices and no implementation of good distribution practices, use of quality control instead of quality assurance as a method to ensure quality of medicines, frequent change of power within the Medicines and Medical Devices Agency (MMDA) leading to lack of long-term strategy and plans, conflict of interest between the different functions of the MMDA, the lack of sufficient funding for the MMDA to conduct its activities and to invest in continuous training of its staff (particularly inspectors) and very weak post-marketing control. Notably, several improvements have been recently introduced, including a roadmap for change for the MMDA, the introduction of good manufacturing practices and the drafting of a quality manual for the Agency. Based on these findings the authors propose a set of priority actions to address existing gaps and draw lessons learned from other countries.