An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology
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...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
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| Online Access: | http://dx.doi.org/10.1186/s40545-020-00261-z |
| _version_ | 1797401337834504192 |
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| author | Lawrence Liberti Rian Marie Extavour Prisha Patel Neil McAuslane |
| author_facet | Lawrence Liberti Rian Marie Extavour Prisha Patel Neil McAuslane |
| author_sort | Lawrence Liberti |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T02:07:29Z |
| format | Article |
| id | doaj.art-3dc04d8cfa044fad9adcdfeb78dbf0ef |
| institution | Directory Open Access Journal |
| issn | 2052-3211 |
| language | English |
| last_indexed | 2024-03-09T02:07:29Z |
| publishDate | 2020-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj.art-3dc04d8cfa044fad9adcdfeb78dbf0ef2023-12-07T15:28:02ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112020-12-0113110.1186/s40545-020-00261-z12315180An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodologyLawrence Liberti0Rian Marie Extavour1Prisha Patel2Neil McAuslane3Centre for Innovation in Regulatory Science,Caribbean Regulatory System,Centre for Innovation in Regulatory Science,Centre for Innovation in Regulatory Science,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.http://dx.doi.org/10.1186/s40545-020-00261-zoptimizing efficiencies in regulatory agencies (opera)caribbean regulatory system (crs)caribbean community (caricom)pan american health organization (paho) |
| spellingShingle | Lawrence Liberti Rian Marie Extavour Prisha Patel Neil McAuslane An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology Journal of Pharmaceutical Policy and Practice optimizing efficiencies in regulatory agencies (opera) caribbean regulatory system (crs) caribbean community (caricom) pan american health organization (paho) |
| title | An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology |
| title_full | An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology |
| title_fullStr | An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology |
| title_full_unstemmed | An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology |
| title_short | An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology |
| title_sort | evaluation of the caribbean regulatory system centralized assessment process for medicines submitted 2017 2018 using the opera methodology |
| topic | optimizing efficiencies in regulatory agencies (opera) caribbean regulatory system (crs) caribbean community (caricom) pan american health organization (paho) |
| url | http://dx.doi.org/10.1186/s40545-020-00261-z |
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