The framework for developmental toxicity testing has remained largely unchanged for over 50 years and although it remains invaluable in assessing potential risks in pregnancy, knowledge gaps exist, and some outcomes do not necessarily correlate with clinical experience. Advances in omics, in silico approaches and alternative assays are providing opportunities to enhance our understanding of embryo-fetal development and the prediction of potential risks associated with the use of medicines in pregnancy. A workshop organised by the Medicines and Healthcare products Regulatory Agency (MHRA), "Predicting the Safety of Medicines in Pregnancy - a New Era?", was attended by delegates representing regulatory authorities, academia, industry, patients, funding bodies and software developers to consider how to improve the quality of and access to nonclinical developmental toxicity data and how to use this data to better predict the safety of medicines in human pregnancy. The workshop delegates concluded that based on comparative data to date alternative methodologies are currently no more predictive than conventional methods and not qualified for use in regulatory submissions. To advance the development and qualification of alternative methodologies, there is a requirement for better coordinated multidisciplinary cross-sector interactions coupled with data sharing. Furthermore, a better understanding of human developmental biology and the incorporation of this knowledge into the development of alternative methodologies is essential to enhance the prediction of adverse outcomes for human development. The output of the workshop was a series of recommendations aimed at supporting multidisciplinary efforts to develop and validate these alternative methodologies.

中文翻译：

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预测怀孕期间药物的安全性：研讨会报告。

发育毒性测试的框架在过去的50多年中基本上保持不变，尽管它在评估怀孕的潜在风险方面仍然具有不可估量的价值，但存在知识空白，并且某些结局不一定与临床经验相关。在组学，计算机方法和替代分析方面的进展为增强我们对胚胎胎儿发育的理解以及与怀孕期间使用药物有关的潜在风险的预测提供了机会。由药品和保健产品监管局（MHRA）举办的研讨会，“预测怀孕期间的药物安全性-一个新时代？”，代表监管机构，学术界，行业，患者，资助机构和软件开发商应考虑如何改善非临床发育毒性数据的质量并获得这些数据，以及如何使用这些数据更好地预测人类妊娠药物的安全性。研讨会代表总结说，根据迄今为止的比较数据，替代方法目前不比常规方法具有更强的预测性，并且不符合监管要求。为了促进替代方法的发展和验证，需要更好地协调跨学科的跨部门交互以及数据共享。此外，更好地理解人类发育生物学并将这些知识纳入替代方法的发展对于增强对人类发展不利结果的预测至关重要。讲习班的输出是一系列建议，旨在支持多学科努力来开发和验证这些替代方法。