PDF(Pubmed)
Abstract：
The Latin America region comprises several countries that do not follow harmonized regulatory requirements for drug product (DP) marketing authorization applications (MAA), resulting in customized registration dossiers for each country. Here, we established a core dossier for multiple MAA in the Latin America region by examining the similarities between regulatory requirements and reconciling their potential discrepancies through discussions among all national regulatory representatives. The core dossier was used in the submission of a new small molecule, NME1, to nine markets. Assessment of the process included the time to submission; the timing, number, and complexity of questions received; and timing of final national regulatory agencies (NRA) evaluation decisions. The core dossier resulted in an accelerated submission timeline for most markets and earlier receipt of NRA queries from some markets, compared with projections. One round of queries of a low or medium complexity was received from all agencies. The receipt of final NRA evaluation decisions was also accelerated in most markets, compared with the best-case approval timeframes. The core dossier approach was also evaluated against the standard submission of a similar small molecule, NME2. In contrast to the core dossier submission of NME1, a second round of questions, and high-complexity questions were received from two markets for NME2. In conclusion, a core dossier has the potential to simplify the regulatory process for both reviewers and applicants in regions that do not share harmonized regulatory requirements, with a consequential acceleration of DP approvals.
摘要：
拉丁美洲地区包括几个不遵循药品（DP）营销授权申请（MAA）统一监管要求的国家，导致每个国家/地区的定制注册档案。这里,我们通过检查监管要求之间的相似性并通过所有国家监管代表之间的讨论来协调其潜在差异，从而为拉丁美洲地区的多个MAA建立了核心档案。核心档案用于提交新的小分子，NME1，到九个市场。对过程的评估包括提交时间；时间，number,以及收到的问题的复杂性；以及最终国家监管机构(NRA)评估决定的时间。核心档案加快了大多数市场的提交时间表，并提前收到了一些市场的NRA查询，与预测相比。从所有机构收到了一轮低或中等复杂性的查询。在大多数市场，最终NRA评估决定的接收也加快了。与最佳案例批准时限相比。还针对类似小分子的标准提交对核心档案方法进行了评估，NME2.与NME1的核心档案提交相反，第二轮问题，从两个市场收到了NME2的高复杂性问题。总之,核心档案有可能为不共享统一监管要求的地区的审核员和申请人简化监管程序，随着DP批准的相应加速。
