Snapshot

The Resolução de Diretoria Colegiada (RDC) 204/2017—Priority Review pathway has been developed by the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil.

This pathway can be used where Drug registration will be classified as priority if it meets one or more of the following criteria: (i) medication used for neglected, emerging or re-emerging disease, public health emergencies or serious debilitating conditions, in situations where there is a therapeutic alternative available or when there is a significant improvement in safety, efficacy or adherence to treatment; (ii) new drug, new pharmaceutical form, new therapeutic indication or new concentration intended for the pediatric population; (iii) vaccines or hyper-immune serums to be incorporated into the National Program of Ministry of Health Immunization; (iv) innovative or new drug, for active pharmaceutical ingredient manufactured in the country; (v) the first three (3) petitions for an unpublished generic drug for each input active pharmaceutical or association and pharmaceutical form, from different economic groups; (vi) medication included in the list of strategic products, within the scope of the Unified Health System (SUS) that is the object of a Public-Private Development Partnership (PDP), through the complete initial submission of all documents and studies provided for in the current regulation..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is - The analysis of the classification in the priority category shall take place within forty-five (45) days of the filing of the corresponding petition. - Within the period provided for, if the classification in the priority category is not confirmed by the competent technical area, the petition shall be rejected. - If the decision of the competent area occurs after the deadline provided for and this decision is for the denial of the request for classification in the priority category, the petition shall be included in the queue for analysis of ordinary petitions, in a position corresponding to its filing date. - In the event of rejection of the petition due to non-confirmation of the classification suggested by the company, the motivation for the decision regarding the non-compliance with the merits of the prioritization shall be published in the Federal Official Gazette. - The deadline for the final decision on the analysis of petitions for registration and post-registration of medicines classified as priority will be: I - 120 (one hundred and twenty) days for petitions for registration of medicine; II - 60 (sixty) days for post-registration petitions. Note: The deadlines will be counted from the filing of the priority petition. Requests for clarification or technical requirements will suspend the counting of the deadlines stated above until they are met. The deadlines mentioned in items I and II above may be extended by up to one third of the original deadline, only once, by means of a reasoned decision issued at least fifteen business days before the end of the original deadline. The deadline for the first manifestation of the competent organizational units regarding the analysis of priority petitions for prior consent in the process of the clinical development dossier, and for prior consent in the process of clinical research of medicine, as well as secondary petitions referring specifically to the prioritized primary process, will be 45 (forty-five) days, counted from the first business day after the filing of the priority petition..