Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)
Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi Publishing Corporation
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5322421/ https://www.ncbi.nlm.nih.gov/pubmed/28280742 http://dx.doi.org/10.1155/2017/7894937 |
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author | do Carmo, Ana Cerúlia Moraes Piras, Stefânia Schimaneski Rocha, Nayrton Flávio Moura Gratieri, Tais |
author_facet | do Carmo, Ana Cerúlia Moraes Piras, Stefânia Schimaneski Rocha, Nayrton Flávio Moura Gratieri, Tais |
author_sort | do Carmo, Ana Cerúlia Moraes |
collection | PubMed |
description | Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products. |
format | Online Article Text |
id | pubmed-5322421 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Hindawi Publishing Corporation |
record_format | MEDLINE/PubMed |
spelling | pubmed-53224212017-03-09 Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA) do Carmo, Ana Cerúlia Moraes Piras, Stefânia Schimaneski Rocha, Nayrton Flávio Moura Gratieri, Tais Biomed Res Int Research Article Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products. Hindawi Publishing Corporation 2017 2017-02-09 /pmc/articles/PMC5322421/ /pubmed/28280742 http://dx.doi.org/10.1155/2017/7894937 Text en Copyright © 2017 Ana Cerúlia Moraes do Carmo et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article do Carmo, Ana Cerúlia Moraes Piras, Stefânia Schimaneski Rocha, Nayrton Flávio Moura Gratieri, Tais Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA) |
title | Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA) |
title_full | Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA) |
title_fullStr | Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA) |
title_full_unstemmed | Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA) |
title_short | Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA) |
title_sort | main reasons for registration application refusal of generic and similar pharmaceutical drug products by the brazilian health regulatory agency (anvisa) |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5322421/ https://www.ncbi.nlm.nih.gov/pubmed/28280742 http://dx.doi.org/10.1155/2017/7894937 |
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