- Tous > Medicine Information and Evidence for Policy > Monitoring and Evaluation
- Tous > Quality and Safety: Medicines > Regulatory Support
- Mots-clés > drug registration
- Mots-clés > harmonization of medicines regulation
- Mots-clés > medicines regulation
- Mots-clés > national regulatory systems - assessment
- Mots-clés > registration of pharmaceuticals
- Mots-clés > regulatory assessment
- Mots-clés > regulatory harmonization
- Mots-clés > regulatory institutional capacity
- Mots-clés > regulatory systems
(2009; 94 pages)
All 15 CARICOM member states were included in the study: Antigua & Barbuda, the Bahamas, Barbados, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, St Kitts & Nevis, St Lucia, St Vincent & the Grenadines, Suriname, and Trinidad & Tobago. The Dominican Republic had been identified as an additional beneficiary of the study in the Pan Caribbean Partnership against HIV/AIDS (PANCAP)/World Bank agreement.
The study was conducted in two main phases, i.e. data collection phase and consolidation phase. Data collection for the regulatory systems assessment in countries was based on the "Guide for Data Collection to Assess Drug Regulatory Performance" developed by WHO (Ratanawijitrasin S, Wondemagegnehu E 2002) that was amended to suit the specific purposes of this study. Both, data collection instruments and implementation work plan were approved by the CARICOM Secretariat and the Technical Advisory Group.
Based on the assessment instrument stakeholder interviews were conducted in Barbados, the Dominican Republic, Guyana, Jamaica, St Lucia, Suriname and Trinidad & Tobago during the period 18 January to 15 February 2009. During the same period questionnaires for self-completion were sent out to the remaining study countries. These countries were supported in person by HERA team members of the CARICOM study on Intellectual Property Rights, TRIPS and Access to Medicines that was conducted in parallel, and through telephonic follow-up by the study team leader.
During the consolidation phase responses collected in countries were analyzed and documented in specific reports for each study country (Volume 2), and summarized for the main report. In addition, study countries' medicines legislation was assessed.
Study findings and resulting recommendations for medicines regulatory harmonization strategies presented in the draft report were discussed with the Technical Advisory Group. This Final Report includes the results of these discussions.