An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology
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ORIGINAL RESEARCH
An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology Noraisyah Mohd Sani, MSc, B. Pharmacy (Hon)1 · Neil McAuslane, PhD2 · Siti Hidayah Kasbon, MSc, B. Pharmacy (Hon)1 · Rosilawati Ahmad, MSc, B. Pharmacy (Hon)1 · Faridah Aryani Md. Yusof, PhD, MSc, B. Pharmacy (Hon)1 · Prisha Patel, MSc2 Received: 20 February 2020 / Accepted: 4 March 2020 / Published online: 28 March 2020 © The Author(s) 2020
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. Keywords National Pharmaceutical Regulatory Agency (NPRA) · Optimising Efficiencies in Regulatory Agencies (OpERA) · Regulatory strengthening · Benchmarking
Introduction As the development and availability of new medicines become increasingly important for healthcare systems, regulatory agencies are strengthening their review of these therapeutics in order to fulfil their mandate to protect and promote public health [1, 2]. This strengthening along with the building of regulatory technical capacity facilitates regulatory * Neil McAuslane [email protected] 1
National Pharmaceutical Regulatory Agency, Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia
Centre for Innovation in Regulatory Science (CIRS), 160 Blackfriars Road, London SE18EZ, UK
2
agencies in their mission to enable patient access to goodquality, safe, and effective medicines in a timely manner. To maximize the use of limited resources, many agencies h
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