RESUMEN
BACKGROUND: The Caribbean Regulatory System is a centralized medicine assessment procedure established to serve the needs of the Member States of the CARICOM region. In order to better understand the effectiveness and efficiency of the processes implemented by the Caribbean Regulatory System for the regulatory assessment of medicines for the region, the system has been participating in the Optimizing Efficiencies in Regulatory Agencies (OpERA) program, a multinational endeavor to characterize the assessment procedures and the corollary metrics associated with medicine review activities in regulatory agencies and regional regulatory initiatives. METHODS: The OpERA tool was used to collect process and specific milestone data for products approved by the Caribbean Regulatory System during 2017 (n = 10) and 2018 (n = 11). RESULTS: The median total approval time was 57.5 days (25th/75th percentiles: 54, 60) in 2017 and 148 days (120, 163) in 2018. The median time to conduct the scientific assessment of the dossier was 37 days (24, 42) in 2017 and 66 (40, 132) days in 2018, within the target of 90 days for this activity. The time increases observed in 2018 were due to staff manpower limitations that reduced the ability of the system to conduct the timely assessment of applications. Based on these observations, recommendations to optimize the effectiveness and efficiency of the Caribbean Regulatory System include a commitment from Member States and partner organizations to the use of the procedure to accelerate product availability, encouraging the use of the Caribbean Regulatory System for non-generic products approved by a reference agency, ensuring the establishment of policy and legal frameworks to facilitate the rapid uptake of Caribbean Regulatory System registrations as marketing authorizations in the Member States, and maintaining the sustainability of the process through a fee-based approach. CONCLUSIONS: The observations obtained using the OpERA methodology indicate the Caribbean Regulatory System is an effective and efficient mechanism to provide recommendations to Member States for important medicines.
RESUMEN
BACKGROUND: The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and quality therapeutics. A new Brazilian law was enacted to provide the agency with greater flexibility. Optimizing Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that seeks to provide benchmarking data that can be used to define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to undertake a retrospective analysis of the timelines associated with important components of the ANVISA regulatory review process to establish a baseline against which the influence of the new law could be measured. METHODS: The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for products approved by ANVISA 2013-2016. RESULTS: For the 138 products approved in this cohort, the overall median approval time was 795 days. ANVISA and submitting companies will need to reduce their review and response times by approximately half in order to meet the total time goal of 365 days. CONCLUSIONS: The observations from this baseline study have identified opportunities for ANVISA and sponsor companies to collaborate to reduce regulatory assessment times while assuring the timely approval of safe and effective, quality medicines. These analyses will be repeated to determine how the provisions of the new Law will impact the activities of ANVISA and the extent of sponsors' contributions to this effort.