To assure the safety and the efficacy of a medicinal product, quality and batch-to-batch reproducibility need to be guaranteed. In the case of parenteral long-acting products, the European Union (EU) and US Regulatory Authorities provide different indications, from the classification to the in vitro release assays related to such products. Despite their relevance, there are few in vitro experimental set-ups enabling researchers to discriminate among products with different in vivo behaviors. Consequently, most copies are authorized through hybrid instead of generic applications. Here, we review the actual regulatory frameworks to evaluate the in vitro release of drugs from polymer-based long-acting parenterals to highlight the directions followed by the Regulatory Agencies in the USA and EU.

中文翻译：

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基于聚合物的肠胃外长效药物产品的监管方面和质量控制：批准复制品的挑战。

为了确保药品的安全性和有效性，需要保证质量和批次间的可重复性。对于肠胃外长效产品，从分类到与此类产品相关的体外释放试验，欧盟（EU）和美国监管机构都提供了不同的适应症。尽管它们具有相关性，但很少有能够使研究人员区分具有不同体内行为的产品的体外实验装置。因此，大多数副本是通过混合而不是通用应用程序授权的。在这里，我们回顾了实际的监管框架，以评估从基于聚合物的长效肠胃外药物的体外释放，以突出美国和欧盟监管机构所遵循的方向。