Brazil - Proposed Resolution n. 355, June 19 2017 Brazilian Health Regulatory Agency (Anvisa) proposed Resolution applies to new medicines designated by ANVISA for rare diseases and establishes special procedures for clinical trials approval, certification of good manufacturing practices and registration of new drugs, designated for the treatment, diagnosis or prevention of rare diseases. The designation of rare disease drug is a prior stage on the approval of clinical trials performed in Brazil, registration of new medicines and certification of good manufacturing practices. ANVISA will publish, through Resolution (RE), a list of medicines designated for rare diseases, and their respective indications. The procedures related to the following topics should be performed in accordance with the specific legislation and complemented with the manifestation of ANVISA regarding the medicine designation as for rare disease: - Submission of clinical drug development dossier (DDCM in Portuguese), specific clinical trial dossier, substantial modification by inclusion of protocol; - Certification of good manufacturing practices - Registration of the medicines Medicines registered through the criteria of this resolution will have a time period of three hundred and sixty-five days to be marketed, counting from the date of publication of the registration. Medicines not marketed within the established period will have the registration cancelled by ANVISA. Products covered: Medicines Proposed date of adoption: NA Proposed date of entry into force: NA Final date for comments: 26 July 2017 | 
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