title: An in-depth analysis of pharmaceutical regulation in the Republic of Moldova.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Based on these findings the authors propose a set of priority actions to address existing gaps and draw lessons learned from other countries.
authors.affiliation: Department of Social Policy, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK ; LSE Health, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Ferrario
authors.affiliation: WHO Regional Office for Europe, World Health Organization, UN City, 51 Marmorvej, Copenhagen 2100, Denmark.
authors.forename: Nina
authors.initials: N
authors.lastname: Sautenkova
authors.affiliation: Department of Social Pharmacy "Vasile Procopisin", State Medical and Pharmaceutical University "Nicolae Testemitanu", 22 Testemitanu Street, Chisinau 2025, Republic of Moldova.
authors.forename: Zinaida
authors.initials: Z
authors.lastname: Bezverhni
authors.affiliation: Center for Health Policies and Studies, 99/1, V. Alecsandrii Street, Chisinau 2012, Republic of Moldova.
authors.forename: Rita
authors.initials: R
authors.lastname: Seicas
authors.affiliation: WHO Country Office in Republic of Moldova, World Health Organization, 29 Sfatul Tarii Street, Chisinau 2012, Republic of Moldova.
authors.forename: Jarno
authors.initials: J
authors.lastname: Habicht
authors.affiliation: Department of Social Policy, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK ; LSE Health, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK.
authors.forename: Panos
authors.initials: P
authors.lastname: Kanavos
authors.affiliation: Department of Social Pharmacy "Vasile Procopisin", State Medical and Pharmaceutical University "Nicolae Testemitanu", 22 Testemitanu Street, Chisinau 2025, Republic of Moldova.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Safta
keywords: Access; Former Soviet Union; Medicines; Regulation; Republic of Moldova
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