Page 42 - GHES-1-2
P. 42
Global Health Econ Sustain Fast-track drug approvals in Brazil
review/fast-track [Last accessed on 2023 Apr 25]. Mayer-Hamblett, N., & VanDevanter, D.R. (2020). Accelerated
approval or risk reduction? How response biomarkers
Fogel, D.B. (2018). Factors associated with clinical trials that fail
and opportunities for improving the likelihood of success: advance therapeutics through clinical trials in cystic fibrosis.
Trends in Molecular Medicine, 26:1068-1077.
A review. Contemporary Clinical Trials Communications,
11:156-164. https://doi.org/10.1016/j.molmed.2020.08.002
https://doi.org/10.1016/j.conctc.2018.08.001 Ministério da Saúde. (2022). Portaria Sctie/MS No 172. Brazil:
Ministério da Saúde.
Gagnon, M.A. (2015). New drug pricing: Does it make any sense?
Prescrire International, 24:192-195. Mostaghim, S.R., Gagne, J.J., & Kesselheim, A.S. (2017). Safety
related label changes for new drugs after approval in the
Gammie, T., Lu, C.Y., & Babar, Z.U.D. (2015). Access to orphan US through expedited regulatory pathways: Retrospective
drugs: A comprehensive review of legislations, regulations cohort study. BMJ, 358:j3837.
and policies in 35 countries. PLoS One, 10:e0140002.
https://doi.org/10.1136/bmj.j3837
https://doi.org/10.1371/journal.pone.0140002
Nash, L. (2016). Fast-track approval of medicines in Australia.
Hwang, T.J., Ross, J.S., Vokinger, K.N., & Kesselheim, A.S. Lancet Oncology, 17:1487.
(2020). Association between FDA and EMA expedited
approval programs and therapeutic value of new medicines: https://doi.org/10.1016/S1470-2045(16)30492-2
Retrospective cohort study. BMJ, 371:m3434. Nguengang Wakap, S., Lambert, D.M., Olry, A.,
https://doi.org/10.1136/bmj.m3434 Rodwell, C., Gueydan, C., Lanneau, V., et al. (2020).
Estimating cumulative point prevalence of rare diseases:
INCA. (2022). INCA Estima 704 Mil Casos de Câncer Por Ano Analysis of the orphanet database. European Journal of
no Brasil Até 2025. Instituto Nacional de Câncer-INCA. Human Genetics, 28:165-173.
Available from: https://www.gov.br/inca/pt-br/assuntos/
noticias/2022/inca-estima-704-mil-casos-de-cancer-por- https://doi.org/10.1038/s41431-019-0508-0
ano-no-brasil-ate-2025 [Last accessed on 2023 Apr 25]. OECD. (2023). Exchange Rates (Indicator). Available from:
Kubler, P. (2018). Fast-tracking of new drugs: Getting the balance http://data.oecd.org/conversion/exchange-rates.htm [Last
right. Australian Prescriber, 41:98-99. accessed on 2023 Feb 02].
https://doi.org/10.18773/austprescr.2018.032 https://doi.org/10.1787/037ed317-en
Lexchin, J. (2015a). Post-market safety warnings for drugs Shahryari, A., Jazi, M.S., Mohammadi, S., Nikoo, H.R.,
approved in Canada under the Notice of Compliance with Nazari, Z., Hosseini, E.S., et al. (2019). Development and
conditions policy. British Journal of Clinical Pharmacology, clinical translation of approved gene therapy products for
79:847-859. genetic disorders. Frontiers in Genetics, 10:868.
https://doi.org/10.1111/bcp.12552 https://doi.org/10.3389/fgene.2019.00868
Lexchin, J. (2015b). Health Canada’s use of its priority review Wong, C.H., Siah, K.W., & Lo, A.W. (2019). Estimation of clinical
process for new drugs: A cohort study. BMJ Open, 5:e006816. trial success rates and related parameters. Biostatistics,
20:273-286.
https://doi.org/10.1136/bmjopen-2014-006816
https://doi.org/10.1093/biostatistics/kxx069
Line, N. (2021). Anvisa Acelera Registro de Medicamentos
de Especialidades. Available from: https:// Zampirolli Dias, C., Godman, B., Gargano, L.P., Azevedo, P.S.,
panoramafarmaceutico.com.br/fast-track-da-anvisa- Garcia, M.M., Cazarim, M.S., et al. (2020). Integrative review
acelera-registro-de-medicamentos-de-especialidades [Last of managed entry agreements: Chances and limitations.
accessed on 2023 May 05]. Pharmacoeconomics, 38:1165-1185.
https://doi.org/10.1007/s40273-020-00943-1
Linger, M., & Martin, J. (2018). Pharmacovigilance and expedited
drug approvals. Australian Prescriber, 41:50-53. Zeng, X., Zhang, Y., Kwong, J.S.W., Zhang, C., Li, S., Sun, F.,
et al. (2015). The methodological quality assessment tools
https://doi.org/10.18773/austprescr.2018.010
for preclinical and clinical studies, systematic review and
Martin, J., & Shenfield, G. (2016). The hazards of rapid approval meta-analysis, and clinical practice guideline: A systematic
of new drugs. Australian Prescriber, 39:2-3. review. Journal of Evidence-based Medicine, 8:2-10.
https://doi.org/10.18773/austprescr.2016.005 https://doi.org/10.1111/jebm.12141
Volume 1 Issue 2 (2023) 11 https://doi.org/10.36922/ghes.0995

