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. 2017:2017:7894937.
doi: 10.1155/2017/7894937. Epub 2017 Feb 9.

Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

Ana Cerúlia Moraes do Carmo  1 , Stefânia Schimaneski Piras  2 , Nayrton Flávio Moura Rocha  2 , Tais Gratieri  3
Affiliations

Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

Ana Cerúlia Moraes do Carmo et al. Biomed Res Int. 2017.

Abstract

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.

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Conflict of interest statement

Ana Cerúlia Moraes do Carmo, Stefânia Schimaneski Piras, and Nayrton Flávio Moura Rocha are employees of the Brazilian Health Regulatory Agency (ANVISA). The remaining authors declare no conflict of interests.

Figures

Figure 1
Figure 1
Number of refused marketing authorization applications in accordance with process submission year.
Figure 2
Figure 2
Distribution of problems related to impurity which led to refusal of marketing authorization application for generic and similar pharmaceutical products.
See this image and copyright information in PMC

References

    1. Brazil, Law nº 6.360, 23th September 1976, Provides information about health surveillance of pharmaceutical drug products, pharmaceutical ingredients and correlatives, cosmetics, sanitizers and other products and other providences, 1976, http://www.planalto.gov.br/ccivil_03/leis/L6360.htm.
    1. IMS Institute for Healthcare Informatics. The Global Use of Medicines: Outlook through 2017. 2013. http://www.quotidianosanita.it/allegati/allegato1501906.pdf.
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    1. Brazilian Health Regulatory Agency. Provides information about similar pharmaceutical drugs registration and other providences. Resolution RDC no 133, May 2003 http://www.anvisa.gov.br/areas/coges/legislacao/2003/REP_RDC_133_2003.pdf.
    1. Brazilian Health Regulatory Agency. Resolution RDC nº 58, 13th october 2014. Provides measures to be adopted bu applicants at Anvisa for similar drug interchangeability with drug reference. 2014 http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2014/rdc0058_10_10_2014.pdf.

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