Thambavita D, Galappatthy P, Jayakody R L
Department of Pharmacology and Pharmacy, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo, 08 Sri Lanka.
J Pharm Policy Pract. 2018 Jun 21;11:14. doi: 10.1186/s40545-018-0141-2. eCollection 2018.
The regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities. The variation is particularly wide between High-income countries (HIC) and lower and middle-income countries (LMIC) with different regulatory frameworks. In this study, document requirements for approval of generic products, approval timelines, and consideration of bioequivalence and/or biowaiver data by Regulatory Authorities (RAs) of 10 selected jurisdictions was studied.
The guidelines and procedures from 5 purposively chosen RA of HIC and4 regional RAs relevant for Sri Lanka were compared with the Sri Lankan National Medicines Regulatory Authority (NMRA). Information available in the official websites of the selected RAs, published journal articles and via personal communication was collected in2016. Drug approval timelines achieved in Sri Lanka was obtained from data available from another study.
Common technical dossier (CTD) format of the International Council on Harmonization (ICH) for registration of pharmaceuticals (ICH:CTD) or the Association of South East Asian Nations (ASEAN) CTD format (ACTD) was used by all RAs studied except Sri Lanka which use its own dossier format. Nine out of ten RAs studied request BE data or justification for not submitting BE data for generic medicines. Sri Lanka requested BE studies only for antimicrobials, antiepileptic drugs and narrow therapeutic index drugs. Biowaivers are allowed for Biopharmaceutics Classification System (BCS)-based Class 1drugs in Singapore and India. USA, EMA, Canada and South Korea allowed biowaiver for BCS Class1and Class 3drugs but Sri Lanka does not accept BW at present. Nine NMRAs out of the ten studied reported legislated timelines for approval of generic pharmaceuticals except Sri Lanka.
Streamlining the drug regulatory systems in LMIC such as Sri Lanka with that of HIC would facilitate an effective drug regulatory system based on reliance on decisions made by stringent regulatory authorities. Findings of this study encourage Sri Lanka to adopt a CTD format for regulatory submission of drug dossiers. Expanding the BE requirement drug list and accepting BCS-based biowaivers for BSC class 1 and 3 drugs during registration of generic drugs when it is scientifically justified is also recommended for Sri Lanka.
不同监管机构对仿制药批准的监管要求以及药品档案编制格式各不相同。在具有不同监管框架的高收入国家（HIC）与中低收入国家（LMIC）之间，这种差异尤为显著。在本研究中，对10个选定司法管辖区的监管机构（RA）批准仿制药的文件要求、批准时间表以及生物等效性和/或生物豁免数据的考量进行了研究。
将5个有针对性选择的高收入国家监管机构以及与斯里兰卡相关的4个地区监管机构的指南和程序与斯里兰卡国家药品监管局（NMRA）进行比较。2016年收集了选定监管机构官方网站上的可用信息、已发表的期刊文章以及通过个人交流获取的信息。斯里兰卡的药品批准时间表来自另一项研究中的可用数据。
除斯里兰卡使用其自己的档案格式外，所有研究的监管机构均采用国际药品注册协调理事会（ICH）的通用技术文档（CTD）格式（ICH:CTD）或东南亚国家联盟（ASEAN）CTD格式（ACTD）。在研究的10个监管机构中，有9个要求提供仿制药的生物等效性数据或不提交生物等效性数据的理由。斯里兰卡仅对抗微生物药物、抗癫痫药物和治疗指数窄的药物要求进行生物等效性研究。新加坡和印度允许对基于生物药剂学分类系统（BCS）的1类药物进行生物豁免。美国、欧洲药品管理局（EMA）、加拿大和韩国允许对BCS 1类和3类药物进行生物豁免，但斯里兰卡目前不接受生物豁免。在研究的10个监管机构中，除斯里兰卡外，有9个报告了仿制药批准的法定时间表。
将斯里兰卡等中低收入国家的药品监管系统与高收入国家的系统进行简化，将有助于建立一个基于信赖严格监管机构所作决定的有效药品监管系统。本研究结果鼓励斯里兰卡采用CTD格式进行药品档案的监管提交。还建议斯里兰卡在仿制药注册时，在科学合理的情况下，扩大生物等效性要求药品清单，并接受基于BCS的1类和3类药物的生物豁免。
