News

By Lívia Honório de Figueiredo

Newsletter 2014.07 – ANVISA publishes resolutions on new procedures relative to marketing authorization in Brazil: RDC #58 and #60/2014

The main law regulating the health system in Brazil – Law #6,360 dated 1976 – establishes that each and every drug available in the pharmaceutical market must be approved by the Ministry of Health. Since the creation of the Brazilian FDA (called ANVISA), this autonomous autarchy subordinated to the Ministry of Health is in charge of issuing marketing authorization for drugs for human use and of establishing specific resolutions in order to regulate each of the existing categories of medicaments, such as the new drugs, generics, similars, biologicals.

According to ANVISA’s requirements, the documentation submitted by the manufacturers of both generic and similar drugs, upon applying for marketing approval, is significantly simplified compared to the reference product (the so-called “abridged process”), as only pharmaceutical equivalence and relative bioavailability/ bioequivalence assays are required to obtain approval for products pertaining to these categories.

It should be noted that, since the publication of Resolutions RDC #133 (new applications for marketing approval) and RDC #134 (similars, already approved), both dated May 29, 2003, ANVISA has begun to require proof of therapeutic equivalence also for similar drugs; therefore, it is estimated that all manufacturers of these products will have complied with such requirement by the end of 2014.

Accordingly, studies of pharmaceutical equivalence and bioavailability/bioequivalence became necessary in order to obtain marketing authorization for both generic and similar drugs, although the latter were not then yet considered to be interchangeable with the reference product.

Back

Last by Lívia Honório de Figueiredo

February 14, 2022

Life sciences patent eligibility in Latin America: a guide

Patents are critical to the life sciences industry and often spark intense and heated debate. To be successful, one key strategy that Life sciences patent eligibility in Latin America: a guide

Ler notícia

December 30, 2021

BPTO publishes phase III of the Patent Prosecution Highway (PPH) Program

The Brazilian Patent and Trademark Office (BPTO) published, by means of Ordinance n° 55, dated December 15, 2021, phase III of the BPTO publishes phase III of the Patent Prosecution Highway (PPH) Program

Ler notícia

November 26, 2020

ANVISA published manuals related to prior consent of patent applications

The Brazilian FDA (ANVISA) published on November 19, 2020, four manuals regarding the analysis of prior consent of patent applications related to ANVISA published manuals related to prior consent of patent applications

Ler notícia