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Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)
المؤلفون المشاركون
Gratieri, Taís
Carmo, Ana Cerúlia Moraes do
Piras, Stefânia Schimaneski
Rocha, Nayrton Flávio Moura
المصدر
العدد
المجلد 2017، العدد 2017 (31 ديسمبر/كانون الأول 2017)، ص ص. 1-10، 10ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2017-02-09
دولة النشر
مصر
عدد الصفحات
10
التخصصات الرئيسية
الملخص 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.
نمط استشهاد جمعية علماء النفس الأمريكية (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
نمط استشهاد الجمعية الأمريكية للغات الحديثة (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
نمط استشهاد الجمعية الطبية الأمريكية (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
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1138772
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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