Ferrario Alessandra, Sautenkova Nina, Bezverhni Zinaida, Seicas Rita, Habicht Jarno, Kanavos Panos, Safta Vladimir
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.
WHO Regional Office for Europe, World Health Organization, UN City, 51 Marmorvej, Copenhagen 2100, Denmark.
J Pharm Policy Pract. 2014 May 1;7:4. doi: 10.1186/2052-3211-7-4. eCollection 2014.
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.
药品监管是确保获得安全有效药品的关键组成部分，但往往被忽视。本研究旨在深入分析摩尔多瓦共和国现行的药品监管情况，包括近期的变化。
利用世界卫生组织（WHO）开展的实地工作数据，以及政策文件审查和定量二手数据分析来实现这一目标。
该分析确定了药品监管影响摩尔多瓦共和国优质药品供应的几种方式。这些包括仿制药注册的生物等效性要求未得到充分实施、良好生产规范未完全实施且良好分销规范未实施、使用质量控制而非质量保证作为确保药品质量的方法、药品和医疗器械局（MMDA）内部权力频繁更迭导致缺乏长期战略和计划、MMDA不同职能之间存在利益冲突、MMDA缺乏足够资金开展活动和投资员工（特别是检查员）的持续培训以及上市后监管非常薄弱。值得注意的是，最近已引入了一些改进措施，包括MMDA的变革路线图、良好生产规范的引入以及该机构质量手册的起草。
基于这些发现，作者提出了一系列优先行动，以解决现有差距，并借鉴其他国家的经验教训。
