Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
DOI:
https://doi.org/10.22239/2317-269X.00835Keywords:
Anvisa, Products Registration, Generic Drug, Similar Drug, Sanitary SurveillanceAbstract
The registration of pharmaceutical drug products involves reviewing company’s administrative aspects as well as technical-scientific aspects related to efficacy, safety and quality. This study evaluated the main administrative reasons for registration refusals of new, generic and similar (branded generic) pharmaceutical drug products in Brazil. Actual submission procedure and process instruction is presented in detail. The aim is to contribute for the improvement of novel applications, reducing non-technical refusals. A retrospective search of registration refusals in 2015 published by the Brazilian Government Official Gazette using Anvisa database, called Datavisa, was performed. The main reasons for non-technical registration refusals of generic and similar pharmaceutical drug products were deadline non-compliance (61.7%), preliminary review (19.8%) and insufficient documentation to permit a substantial full review (18.5%). Disclosure of administrative reasons behind failed applications is a step forward on regulatory transparency, and on internal and external orientation about regulatory mechanisms.Downloads
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