Table 1 Chronology of main laws, regulations, and decrees regarding branded generics, generics, and general product quality and bioequivalence, 1994–2011
From: The Brazilian private pharmaceutical market after the first ten years of the generics law
Year | Branded generics | Generics |
|---|---|---|
Law/regulation/contenta | Law/regulation/contenta | |
1994 | Normative instruction n°1 - Requirements for the registration of similar medicines | |
1996 | Law 9279 - Regulates the rights and obligations regarding industrial property | |
1999 | Law 9787 - Generics Law | |
Resolution RDC 391 - States that for a product to be registered as generic there is a need to prove bioequivalence. | ||
Decree 3181 - Regulates Law 9787 | ||
2000 | Resolution RDC 92 - Similar medicines can be marketed and identified by trade name or mark that distinguishes the products from those of other manufacturers | Resolution RE 74 - Approval of the first registrations of generic medicines |
2001 | Resolution RES 36 - Similar medicines obligated to start presenting commercial names; a deadline of 180 days was given to industries to comply | Resolution RDC 10 - Included a list of medicines that for safety reasons could not be registered as generic drugs; it is a revision of the RDC 391. |
Resolution RDC 47 - Regulating characteristics of the packaging of generics | ||
Decree 3961 Updates the definitions of similar, reference and generic drugs | ||
2002 | Resolution RDC 157 - Established the requirements for pharmaceutical equivalence studies for similar drugs | Resolution RDC 84 - Modifies the list of products identified in resolution RDC 10 |
2003 | Resolution RDC 133 and RDC 134 - Regulations for the registration of similar medicines requiring products to undergo, by 2014, the same relative bioavailability and pharmaceutical equivalence testing, required from the beginning for generic medicines | Resolution RDC 135 - Approves the Technical Regulation for Generic Drugs; repeals RDC 391 and RDC 84 |
2007 | Resolution RDC 17 - Similar medicines were obligated to present the same documents for licensing as needed for generics | Resolution RDC 16 - Approves the Technical Regulation for Generic Drugs; repeals RDC 135 |
2010 | Resolution RES 16 - Amending and repealing legal texts related to the presentation prior to Anvisa protocol bioequivalence study; repeals RDC 17. |