Cheaib N
a ClinGroup Holding , Hazmieh-Beirut , Lebanon.
Account Res. 2016;23(1):23-30. doi: 10.1080/08989621.2014.956868.
In view of the MENA increasing participation in multinational trials and the increasing number of national/regional trials, this article explores potential areas of pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Regulatory silence on expedited reporting requirements creates confusion for local sites that are part of multinational trials. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing local pharmacovigilance guideline, in sync with global practice cannot be overemphasized.
鉴于中东和北非地区越来越多地参与跨国试验以及国家/地区试验的数量不断增加，本文探讨了药物警戒中需要改革的潜在领域，并为建立一个强大的安全报告系统提供了建议。监管机构对快速报告要求保持沉默，这给参与跨国试验的当地机构带来了困惑。对于方案规定的或作为研究终点的严重不良事件不允许豁免，同时缺乏对因果关系作为报告标准的强调，给监管审查增加了大量无信息价值病例的负担。尽管全球都关注研发安全更新报告，但当地监管机构尚未坚持实时更新药物的累积安全概况。诸如仿制药试验的报告要求、妊娠报告以及死亡/危及生命事件宽松的报告期限等问题需要关注。最后，制定与全球实践同步的全面的当地药物警戒指南的必要性再怎么强调也不为过。
