Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities

Abstract

BackgroundThe 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.MethodsThe 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.ResultsCommon 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.ConclusionsStreamlining 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.

Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities

“…FDA Ghana has also developed adequate technical capacity to assess these generic applications. Due to the demand for generic medicines in LMICs, most NMRAs dedicate significant resources to evaluate applications for marketing authorisations quickly so that the healthcare system can enjoy these cost-saving benefits [14]. Additionally, these generics products can often be assessed by pharmacists rather than physicians (bioequivalence and manufacturing quality) as is reflected in the Ghana, where 25 of the 26 internal reviewers are pharmacists.…”

“…It was also reported that the average time between generic drug application submission and approval in the USA was about 6 months and 10 months for priority review and standard review, respectively [14,20]. The approval timeline for generics was 175 working days and 180 calendar days for Australia and Canada, respectively [14,20].…”

“…It was also reported that the average time between generic drug application submission and approval in the USA was about 6 months and 10 months for priority review and standard review, respectively [14,20]. The approval timeline for generics was 175 working days and 180 calendar days for Australia and Canada, respectively [14,20]. Therefore, the median approval times for generics approved in Ghana, which was in the range of 81 to 181 calendar days, were comparable to the approval timelines in the USA, Australia and Canada.…”

“…Of the generics, 97% were pharmaceuticals and were processed by the full review pathway with relatively shorter review times when compared to NASs, and the approval times for processing these generics were within the target timelines. The review types and numbers reflect the large volumes of generic applications compared with NASs originating from low-and middleincome countries (LMICs) [14].…”

In Vivo Bioequivalence Study of Drug: An Analysis of Bidding in Vietnam Period 2018 - 2022

“…Như tại Mỹ, các thuốc generic khi đăng ký lưu hành tại Cục Quản lý Thuốc và Thực phẩm Hoa Kỳ (FDA) đều phải nộp báo cáo nghiên cứu TĐSH [4]. Một số quốc gia thì chỉ yêu cầu nộp báo cáo nghiên cứu TĐSH) bắt buộc đối với một số hoạt chất, dạng bào chế như Srilanka, Campodia, Nepal [5,6],… Tại Việt Nam hiện mới áp dụng bắt buộc đối với 26 Dược chất và một số dạng bào chế bắt buộc phải nộp Báo cáo số liệu nghiên cứu TĐSH trong đăng ký lưu hành thuốc tại Việt Nam [7].…”