rdc n 205 december 28th 2017. this resolution establishes special procedure for approval of clinical trials good manufacturing practices certification and registration of new medicines for treatment diagnosis or prevention of rare diseases. this resolution applies to new medicines for rare diseases.the special procedure applies to i clinical trials authorization to be performed in brazil for the evaluation of medicines for rare diseases ii - certification of good manufacturing practices of medicines for rare diseases iii market authorization of new medicines for rare diseases.a medicine for a rare disease shall be considered a medicine intended to treat diagnose or prevent a rare disease and i - is used in a serious debilitating condition ii - proposes to change in a clinically significant way the disease evolution or to make possible the remission of the disease.the request of approval for clinical trials and registration of a new medicine for rare diseases is established in this resolution.if it is not confirmed during the technical analysis that the petitions for approval of clinical trials and registration of new medicine refers to rare disease the petition will be rejected.submission of clinical medicine development dossier specific clinical trial dossier substantial modification by inclusion of protocol should be performed according to specific legislation regarding clinical trials in brazil added by the documentation established in this resolution.the request for registration of a new rare disease medicine must be carried out according to specific legislation for each regulatory category added by the documentation described in this resolution.supplemental data and additional evidence may be allowed after the registration has been granted by means of a signature of an agreement between anvisa and the company requesting registration. failure to comply with the agreement may lead to cancellation of the registration.anvisa may permit the use of an international comparator medicine registered with another regulatory authority under the terms set forth in this resolution in the event of a request for registration of a rare disease medicine with the same registered medicine ifas.companies that submit a request for registration of new medicine in accordance with this resolution must present a maximum price definition dossier concomitantly with the registration requestfor applications for registration of new medicines for rare diseases it does not apply the provisions of art. 2 of the resolution of the collegiate board of directors - rdc n 20 of 10 april2013.this resolution changes the text of 2 of art. 47 of the resolution of the collegiate board of directors - rdc n 9 of 20 february 2015.