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

P. Galappatthy,R. L. Jayakody,D. Thambavita

doi:10.1186/s40545-018-0141-2

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.

Highlights

The regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities
Definition of generic drugs used by Regulatory Authority (RA) Definition and subsequent explanations provided for ‘generic medicine’ by the selected RAs in their guidelines contained common criteria [7, 8, 10, 14,15,16,17,18,19] of active drug substance being qualitatively and quantitatively same with an already approved product, having the same or comparable dosage form, having the same route of administration, and demonstrating bioequivalence with a reference product.there were differences in consideration of salts or esters as the same active substance, in the reference product
Sri Lanka was using a format which it had developed based on the World Health Organization (WHO) recommendations for drug registration but not claimed to be either International Council on Harmonization (ICH):common technical dossier (CTD) or ACTD [31]

Summary

Introduction

The regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities. Some RAs in LMIC have regulatory systems that rely on the review process already done by ICH member countries or ICH observer countries. This process would be easier if a common dossier format is used during regulatory submission. Most RAs have published drug approval timelines in order to establish an efficient and transparent drug regulatory process in their countries. They revise these timelines based on past performance [9]

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