Global Regulatory Science and Policy for Latin America, Sanofi, PH Evolution, Ciudad de Panamá, Panamá.
Global Regulatory Science and Policy for Latin America, Sanofi, PH Evolution, Ciudad de Panamá, Panamá.
Clin Ther. 2022 Aug;44(8):1107-1128. doi: 10.1016/j.clinthera.2022.06.005. Epub 2022 Jul 4.
For more than a decade, the World Health Organization, Pan American Health Organization, Pan-American Network or Drug Regulatory Harmonization, and the International Conference of Drug Regulatory Authorities, have encouraged regulators to adopt reliance and recognition pathways to reduce duplication, improve efficiency and efficacy, and strengthen regulatory capabilities, in order to facilitate marketing authorization approval, thereby maintaining supply chain integrity. Several factors have limited the more widespread implementation of reliance pathways in Latin America, among which is having the appropriate legal tools in place between and among agencies. Key among these tools are the Memorandum of Understanding (MOU) and cooperation agreements. Herein we have reviewed the content and the characteristics of MOUs and cooperation agreements available on the official websites of the regulatory agencies of the region (we found 11 multilateral MOUs and 8 cooperation agreements published), signed by Latin American agencies and interregional organizations. In this commentary, common characteristics are identified and recommendations for further implementation are made to promote communication, information sharing, and trust, thereby supporting the broader use of reliance pathways in the region.
十多年来，世界卫生组织、泛美卫生组织、泛美药品监管协调网络或药物监管协调、以及国际药品监管机构会议，一直鼓励监管机构采用依赖和认可途径，以减少重复，提高效率和效果，并加强监管能力，从而促进药品上市许可批准，从而保持供应链的完整性。有几个因素限制了依赖途径在拉丁美洲更广泛的实施，其中包括机构之间和机构内部有适当的法律工具。这些工具中主要的是谅解备忘录（MOU）和合作协议。在此，我们审查了该地区监管机构官方网站上（我们发现 11 个多边谅解备忘录和 8 个合作协议已发布）的 MOU 和合作协议的内容和特点，这些协议由拉丁美洲机构和区域间组织签署。在这篇评论中，确定了共同的特征，并提出了进一步实施的建议，以促进沟通、信息共享和信任，从而支持在该地区更广泛地使用依赖途径。
