In Brazil, bioequivalence studies were initiated in 1999 with the law that established generic medicines and the creation of the Brazilian Health Surveillance Agency—ANVISA (Law 9782/1999). Since then, several regulations have been published with the aim of establishing the necessary requirements for the registration of generic medicines, including resolutions on pharmaceutical equivalence and bioequivalence studies. The current resolution that deals with the conduct of bioequivalence studies is RDC 742/2022 but will likely soon undergo further revision considering the recent recommendations of the ICH M13A guideline. This resolution provides some innovations in relation to the previous one (RE 1170/2006), establishing from this date the need to carry out bioequivalence studies for semi-solid topical products containing corticosteroids. In this way, it can be considered that Brazil is going through a second phase of development of bioequivalence studies. This chapter traces the trajectory covered so far, bringing all the new Brazilian regulations adopted since the publication of the 2018 edition of this book and provides a history of the resolutions that deal with the criteria established for the implementation of generic medicines in the country, which is directly related to the development of bioequivalence studies in Brazil.