An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

Abstract

Introduction The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides benchmarking data that can define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to determine where time is spent in the NPRA approval process and to form a baseline to measure the performance improvements. Methods The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for new active substances and biosimilars approved by NPRA in 2017. Results In 2017, 25 new active substances and 1 biosimilar were approved by NPRA in a median of 515 days, representing both agency and applicant time. The median time between dossier receipt and the initiation of NPRA scientific assessment was 135 days, but there was a wide variation in queuing time. The median total assessment time was 279 days (agency and applicant timing). NPRA took a median of 166 days; applicants took a median of 131 days to respond to deficiency questions, with up to 6 cycles of review required for approval and 65% of applications requiring 4-5 cycles to provide satisfactory responses. Conclusions As a result of these data, NPRA proposes three improvements: target start for scientific assessment 100 days after file acceptance, a maximum of 5 review cycles, and applicant response time limited to 6 months. These results will serve as a baseline for further assessment.

Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice and Recommendations

“…The description of 43 articles is presented in Table 1 . 11 - 15 , 18 - 20 , 26 - 60 The research design included literature review (n = 3), 28 , 32 , 49 expert interview (n = 1), 48 empirical analysis (n = 2), 43 , 52 comparative analysis (n = 7), 12 , 15 , 35 , 42 , 47 , 58 , 59 retrospective analysis (n = 2), 19 , 41 questionnaire (n = 10), 14 , 20 , 26 , 27 , 37 - 40 , 55 , 56 description analysis (n = 6), 11 , 13 , 33 , 36 , 45 , 60 and mixed methods (n = 12). 18 , 29 - 31 , 34 , 44 , 46 , 50 , 51 , 53 , 54 , 57…”

“… 18 , 30 , 35 , 50 , 54 , 57 Additionally, 5 studies were designed to analyse the drug review process. 19 , 31 , 34 , 40 , 47 Two studies focused on measuring the effectiveness of capability building in healthcare, 43 , 60 while 3 studies concentrated on post-marketing surveillance, 51 , 52 , 55 particularly regarding the circulation and safety of drugs. One study aimed to enhance the vaccine regulatory system in China, 32 another aimed to evaluate the level of adherence to good review practices (GRevP), 46 and 1 study aimed to identify the allocation of resources for capability building.…”

“…Among the 43 included studies, 15 studies covered multiple regulatory functions 11 , 13 , 15 , 18 , 20 , 27 , 32 - 34 , 42 , 44 , 45 , 50 , 54 , 57 while the remaining 28 studies focused on only 1 function when evaluating the regulatory capacities of NRAs. 12 , 14 , 19 , 26 , 28 - 31 , 35 - 41 , 43 , 46 - 49 , 51 - 53 , 55 , 56 , 58 - 60 Apart from 6 of the studies 11 , 13 , 18 , 27 , 32 , 42 which fully adopted the 9 GBT indicator categories when evaluating the functions of interest, the remaining studies adopted only some of the GBT indicator categories and sub-indicators whenever deemed relevant by the researchers. In 5 studies, 12 , 15 , 29 , 33 , 34 a combination of indicators from different benchmarking tools or programmes were used as measurements of the regulatory capacities.…”

An Evaluation of the Swissmedic Regulatory Framework for New Active Substances

“…CIRS has been benchmarking regulatory authorities globally to support efficient, effective, and fit for purpose regulatory systems. This publication forms part of CIRS OpERA work to optimise efficiencies in regulatory authorities [ 7 , 11 ]. The breakdown of company and agency time as well as international comparisons demonstrate the benefits of such as study to understand where time is spent in regulatory review process and how that differs across regulators, as well as the ability to demonstrate the impact of measures introduced by agencies to improve their process.…”

“…The following metrics were collected in addition to the milestones described in Tables 1 and 2 : product name; applicant name; company; compound type; ATC code (as defined by the WHO); use of work-sharing and collaborative reviews via Access Consortium ( https://www.swissmedic.ch/swissmedic/en/home/about-us/international-collaboration/multilateral-co-operation-with-international-organisations---ini/multilateral-co-operation-with-international-organisations---ini.html ) and Project Orbis ( https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis ), respectively; review type: standard review, fast-track authorisation procedure (FTP) [ 7 ]; or the Procedure with Prior notification (PPN) [ 8 ]. Other authorisation pathways, such as the conditional/time-limited marketing authorisations, exist at Swissmedic as well as in other jurisdictions, but were not investigated in this study.…”