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Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America

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Abstract

Countries worldwide have introduced new regulations to accelerate drug regulatory review to afford faster access to medicines, mainly for patients with no or limited therapeutic alternative without compromising the quality, efficacy, and safety of the drug. We mapped and analyzed accelerated regulatory pathways in 19 countries from Latin America (LATAM). Pathways included acceptance of Phase II studies, when justified, and requirement of a Certificate of Pharmaceutical Product (CPP) for regulatory submission or approval for a drug. We present a regional regulatory overview of innovative pathways to accelerate assessment of medicines by regulators to benefit patients in need. Most LATAM regulators we surveyed have implemented accelerated pathways. Adoption of good regulatory practices is key for success (World Health Organization, WHO, Good Regulatory Practices: guidelines for national regulatory authorities for medical products (World Health Organization, WHO, Good Regulatory Practices: guidelines for national regulatory authorities for medical products. World Health Organization QAS/16.686. WHO, 2016. https://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodRegulatory_PracticesPublicConsult.pdf).

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Acknowledgements

The authors acknowledge Rosana Mastellaro (SINDUSFARMA) for assistance in writing this manuscript.

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  1. Chemin de l’Oche l’Abbé 3, 1112, Echichens, Switzerland

    Ana Padua, Livia Partika, Denise Bonamici, Juliana Rahal Cabello, Cristiane Kohiyama, Paula Spinardi, Anabelle Castro, Alessandra Rolim & Francisco Souto

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  1. Ana Padua
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  2. Livia Partika
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Padua, A., Partika, L., Bonamici, D. et al. Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America. J Public Health Pol 41, 481–495 (2020). https://doi.org/10.1057/s41271-020-00245-y

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