Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)
Joint Authors
Gratieri, Taís
Carmo, Ana Cerúlia Moraes do
Piras, Stefânia Schimaneski
Rocha, Nayrton Flávio Moura
Source
Issue
Vol. 2017, Issue 2017 (31 Dec. 2017), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2017-02-09
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Carmo, Ana Cerúlia Moraes do& Piras, Stefânia Schimaneski& Rocha, Nayrton Flávio Moura& Gratieri, Taís. 2017. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA). BioMed Research International،Vol. 2017, no. 2017, pp.1-10.
https://search.emarefa.net/detail/BIM-1138772
Modern Language Association (MLA)
Carmo, Ana Cerúlia Moraes do…[et al.]. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA). BioMed Research International No. 2017 (2017), pp.1-10.
https://search.emarefa.net/detail/BIM-1138772
American Medical Association (AMA)
Carmo, Ana Cerúlia Moraes do& Piras, Stefânia Schimaneski& Rocha, Nayrton Flávio Moura& Gratieri, Taís. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA). BioMed Research International. 2017. Vol. 2017, no. 2017, pp.1-10.
https://search.emarefa.net/detail/BIM-1138772
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1138772