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ANVISA – The addition to the application of origin should be submitted by electronic system – Sistema Solicita
In order to improve the link between applications for addition to their respective applications [...]
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ANVISA – Process Optimization for importing Cannabis-based products by individuals in Brazil – updated on November 29th
In October 2021, some important rules were published for the process of importing [...]
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ANVISA – Agency accepted in international inspection program
The Brazilian Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA) was [...]
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Whitepaper – Differences between CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient) – ANVISA and CEP (Certificate of Suitability) – EDQM
In April 2021, the New Regulatory Framework for APIs in Brazil completed one year since its [...]
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Whitepaper: Medicinal Cannabis Products – Regulatory differences between Brazilian and Mexican Legislations
We have published our new Whitepaper that describes the main differences between Mexican and [...]
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ANVISA – Update of the Guideline 20/2019 on topical and transdermal products
ANVISA published the second version of Guideline 20/2019, which provides guidance on quality [...]
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Whitepaper: Diffferences between CTD Brazil and UE: a look at CMC requirements
Our daily lives at Vita are full of discussions about technical and regulatory differences in [...]
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ANVISA – Public Consultation for Revision of RDC 47/2009, which establishes the rules for drug package leaflet
On December 2020, ANVISA published the Public Consultation for Revision of DRC Nº 47 of [...]
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ANVISA – Resolution RDC 753/2022 – Review to RDC 200/2017 – Marketing Authorization of New, Innovative, Generic and Similar Medicinal Products – updated on October 10th, 2022
On October 7, at Public Ordinary Meeting ANVISA 19/2020, it was approved the draft for Public [...]
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ANVISA – Questions & Answers on RDC 359/2020, which instituted DIFA and CADIFA for API used in the manufacture of Drug Products
On September 28th, ANVISA published the document Questions & Answers on RDC 359/2020, which [...]
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ANVISA – Service Guidance on flows for analysis of drug product application
On September 23, ANVISA published Service Orientation (OS) 90/2020, from the General Management [...]
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ANVISA – New Legislation in Pharmacovigilance
On July 29th, it was published on Brazilian Official Gazette (DOU) the RDC Nº 406/2020, [...]
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