References
- Choong SSF, Lim JCW, Tominaga T. Developing key performance indicators to measure the progress of regional regulatory convergence and cooperation in Asia-Pacific economic cooperation (APEC). AAPS Open. 2018;4:4.
- Liberti L, Breckenridge A, Hoekman J, et al. Accelerating access to new medicines: current status of facilitated regulatory pathways used by emerging regulatory authorities. J Pub Health Pol. 2016;37:315–333.
- Luigetti R, Bachmann P, Cooke E, Salmonson S. Regulatory collaboration, collaboration, not competition: developing new reliance models. WHO Drug Info. 2016;30:558–566
- World Health Organization. Good regulatory practices: guidelines for national regulatory authorities for medical products https://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodRegulatory_PracticesPublicConsult.pdf. Accessed 12 January 2020.
- Freitas, M. PAHO – Regulatory reliance principles: concept note and recommendations. 11:36, 17 de September de 2019. http://prais.paho.org/en/paho-regulatory-reliance-principles-concept-note-and-recommendations/ Accessed 12 January 12, 2020.
- World Health Organization. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems. https://www.who.int/medicines/regulation/benchmarking_tool/en/ Accessed 3July 2019.
- Preston C, Freitas Dias M, Peña J, Pombo ML, Porrás A. Addressing the challenges of regulatory systems strengthening in small states. BMJ Glob Health. 2020;5:e001912. https://doi.org/10.1136/bmjgh-2019-001912.
- CARPHA. http://new.carpha.org/Portals/0/Documents/Caribbean_Pharmaceutical_Policy-2013.pdf Accessed 8 January 8 2020.
- Pan American Health Organization. National Regulatory System: organizational structure and legal basis, and the provisions for medicines regulation in the Americas. PRAIS — regional platform on access and innovation for health technologies. Washington: PAHO; PRAIS Bull 2015;2(1).
- Preston C, Chahal HS, Porrás A, Cargill L, Hinds M, Olowokure B, et al. Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states. Rev Panam Salud Publica. 2016;39:262–268.
- Rodier C, Patel P, McAuslane N, Liberti L: CIRS R&D Briefing 74: The OpERA programme: Measuring process and performance in regulatory agencies. January 2020. Centre for Innovation in Regulatory Science. London, UK. accessed at: https://www.cirsci.org/publications/cirs-rd-briefing-74-opera-programme/.
- Hashan H, Aljuffali I, Patel P, Walker S. The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore. Pharm Med. 2015. https://doi.org/10.1007/s40290-015-0124-4.
- MashakiCeyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore. Front Pharmacol. 2018. doi.org/https://doi.org/10.3389/fphar.2018.00009.
- Keyter A, Salek S, Banoo S, Walker S. The south African medicines control council: comparison of its registration process with Australia, Canada, Singapore, and Switzerland. Front Pharmacol 2019 https://doi.org/10.3389/fphar.2019.00228.
- McAuslane N, Cone M, Collins J, Walker S. Emerging markets and emerging agencies: a comparative study of how key regulatory agencies in Asia, Latin America, the Middle East and Africa are developing regulatory processes and review models for new medicinal products. Drug Inform J. 2009;43:349–359.https://doi.org/10.1177/009286150904300314.
- World Health Organization. The WHO prequalification programme and the medicines patent pool: a primer. 2011. http://apps.who.int/prequal/info_general/documents/FAQ/PQ_PatentPool.pdf Accessed 12 January 2020.
- CARPHA. http://new.carpha.org/What-We-Do/Programmes-and-Projects/CRS/Operational-Policy Accessed 12 January 2020.