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Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada

PURPOSE: Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. OBJ...

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Detalles Bibliográficos
Autores principales: Kuribayashi, Ryosuke, Appleton, Scott
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629127/
https://www.ncbi.nlm.nih.gov/pubmed/28577294
http://dx.doi.org/10.1007/s40268-017-0186-8
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author Kuribayashi, Ryosuke
Appleton, Scott
author_facet Kuribayashi, Ryosuke
Appleton, Scott
author_sort Kuribayashi, Ryosuke
collection PubMed
description PURPOSE: Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. OBJECTIVE: The objective of this study was to examine generic drug reviews in Japan and Canada. METHODS: We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. RESULTS: This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. CONCLUSIONS: The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.
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spelling pubmed-56291272017-10-17 Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada Kuribayashi, Ryosuke Appleton, Scott Drugs R D Original Research Article PURPOSE: Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. OBJECTIVE: The objective of this study was to examine generic drug reviews in Japan and Canada. METHODS: We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. RESULTS: This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. CONCLUSIONS: The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada. Springer International Publishing 2017-06-02 2017-09 /pmc/articles/PMC5629127/ /pubmed/28577294 http://dx.doi.org/10.1007/s40268-017-0186-8 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research Article
Kuribayashi, Ryosuke
Appleton, Scott
Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada
title Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada
title_full Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada
title_fullStr Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada
title_full_unstemmed Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada
title_short Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada
title_sort comparison of generic drug reviews for marketing authorization between japan and canada
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629127/
https://www.ncbi.nlm.nih.gov/pubmed/28577294
http://dx.doi.org/10.1007/s40268-017-0186-8
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