Newsletter
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.
Last related news
July 19, 2024
ANPD in the spotlight: Brazilian Data Protection Authority approves Regulation about the DPO and discloses new platform for data subject’s requests
Regulation for Data Protection Officer’s Practice This week (Tuesday, 16), the Brazilian Data Protection Authority (ANPD) approved the Resolution CD/ANPD No. 18, … ANPD in the spotlight: Brazilian Data Protection Authority approves Regulation about the DPO and discloses new platform for data subject’s requests
July 17, 2024
PPH in Brazil: case limit for 2024 has been reached
The Brazilian Patent and Trademark Office (BPTO) has just published a notification informing that the annual limit of 800 Patent Prosecution Highway … PPH in Brazil: case limit for 2024 has been reached
July 15, 2024
Ministry of Finance publishes new rules for betting in Brazil
The Ministry of Finance has published an Ordinance aimed at regulating the betting and gaming market in Brazil. Ordinance SPA/MF No. 1,143, … Ministry of Finance publishes new rules for betting in Brazil