By Maria Claudia B. de Almeida Souza
October 28, 2014
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.
Share:
Last by Maria Claudia B. de Almeida Souza
October 28, 2014
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.
October 1, 2014
Going Beyond its Remit
A review od ANVISA's role in the prosecution of pharma patent applications and the latest developments reveals ongoing controversies, as Joao Luis Vianna and Maria Claudia Souza report.
April 13, 2013
Newsletter 2013.02 – Recent developments regarding examination of pharma patent applications
Brazilian PTO’s new Resolution No. 80 of March 19, 2013 sets forth rules for granting priority examination for patent applications related to pharmaceutical products and processes, and equipments and materials related to public health
The Brazilian PTO published Resolution No. 80, on March 19, 2013 in the Official Gazette, which establishes the proceedings for requesting priority examination of patent applications related to pharmaceutical products and processes, and equipments and materials related to public health. We are pleased to hereby enclose a complete English language version of the resolution for your review.
According to the new resolution, now in full force, priority for the examination of patent applications related to public health may be requested by:
(i) The Ministry of Health when the object of the patent is considered strategic to the policies within the National Public Health System (the SUS) — the possibility of having a