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T-21: Benchmarking Regulatory Processes in Emerging Markets Through Key Performance Indicators
Lawrence Eugene Liberti
Centre for Innovation in Regulatory Science (CIRS) United States
Identify quality indicators in regulatory review to help regulators integrate a practice of tracking and measuring regulatory performance and promote continuous improvements including potential reductions in review and approval times without compromising product safety, efficacy or quality
In a pilot study among regulatory agencies in emerging markets, general information was collected via electronic questionnaire about each agency and four or five reviewed products. Common milestones were used to collect regulatory review times from regulatory agencies in the emerging markets
Nine agencies completed the questionnaire. To characterise the data set when conducting analyses, qualitative information requested for applications for each product included sponsor; generic name and compound code; trade name; compound type; form of review, that is, standard, fast track, accelerated approval or priority application; general therapeutic class and new active substances. Milestones identified included receipt of dossier, start of first scientific assessment, completion of first scientific assessment, deficiency questions sent out (first question sent), sponsor response (last response returned), start of the second scientific assessment, advisory committee date and date of marketing authorisation. Four of the nine agencies collected information about all of these milestones. Information was not collected by two agencies regarding when deficiency questions were sent out, not collected by two agencies regarding when responses were returned, not collected by two agencies regarding the start of the second scientific assessment and not collected by three agencies regarding advisory committee dates. At one agency it was unknown if information was collected about the start of the scientific assessment. Median regulatory approval times from date of submission to date of approval for four or five new active substances approved from 2012 through 2015 at the six agencies were variable at 185, 199, 246, 273, 455, and 515 days. At one of the six agencies, 100% of the review time, including validation, queue, advisory committee time and review cycles time was spent by the agency and not the company; at the other five agencies, the agency spent 57%, 59%, 77%, 82%, and 81% of the review time. The greatest proportion of agency time was spent from the receipt of dossier to first scientific assessment and from the beginning to the end of that assessment. The greatest proportion of company time was spent from the time of second outcome letter until its response.
The timeliness of reviews is only one aspect of measuring regulatory performance. The quality of the process from construction of the dossier to the ultimate regulatory decision must also be considered and measured. This measurement guarantees expected standards, instils confidence amongst stakeholders and achieves universal acceptability of reviews. CIRS has experience developing and using qualitative tools for identifying key performance indicators to measure regulatory performance including Quality Scorecards, gap analyses, process mapping and identification of good review practices. The successful first phase of the CIRS programme to measure regulatory agency performance is currently being expanded though its Optimising Efficiencies in Regulatory Agencies (OpERA) programme, with the input of regulatory agencies from Asia, Latin America, Africa, and the Middle East. It is envisioned that ongoing, systematic assessment of the processes that occur during the review of a marketing authorisation will provide the tools to help integrate a practice of collecting ongoing information to encourage consistent internal tracking and assessments, provide agencies with factual results that can be used to help better convey their mission and needs to policy makers and other stakeholder, evaluate how the organisational processes used in the review of marketing authorisations compare with peer organisations, assess the practices and outcomes of regional regulatory alignment initiatives by monitoring the use and effectiveness of work sharing/referencing across participating agencies, identify best practices that improve performance and encourage opportunities to share information on common practices and inform global regulatory strengthening projects, including those supported by the World Health Organization, the Bill and Melinda Gates Foundation and regional regulatory centres of excellence.