Brazil | Draft criteria for acceptance of the in vitro and in vivo tests

Draft Text 1 is available for download in the following languages Portugese

Description - Article 1 This Draft Resolution establishes the criteria for acceptance of the in vitro and in vivo tests necessary to prove therapeutic equivalence for the granting and renewal of registration and post-registration changes in nasal and oral inhalants medicines with synthetic active principles classified as new, generic and similar. Article 2 Single paragraph. In the case of new medicine products, the scope of this resolution is limited to medicine products containing active principles within the approved therapeutic range where therapeutic equivalence studies may replace clinical studies of Phase II and III, as defined by Resolution - RDC 60, 10 October 2014 and its updates. Article 4 All requirements for conducting the pharmaceutical equivalence study of nasal and oral inhalation medicines and for the preparation of reports shall meet the criteria established in this resolution, as well as in Resolution RDC 31, 11 August 2010, and its updates, which provides the Guide for Study Execution and Elaboration of the Pharmaceutical Equivalence Report and Dissolution Profile. Article 14 In addition to the requirements presented in this Resolution, pharmacokinetic studies for the purpose of proving the relative bioavailability/bioequivalence of nasal medicines products and oral inhalers should meet the criteria established in other regulations on the subject. Art 45 The relative bioequivalence/bioavailability study may be dispensed for other generic and new generic drug dosages, provided that the criteria for pharmacokinetic linearity and proportionality of the formulations are met, as determined by Resolution - RDC 37, 3 August 2011, which provides the Guide for Exemption and Substitution of Relative Bioavailability Studies/Bioequivalence Paragraph 1 The other dosages should use the same device as the dosage under study in vivo. Paragraph 2 The comparative performance tests between test drug and reference of the same dosage, as described in Section I of Chapter II of this Resolution, shall also be presented in the above exemption cases