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or new drug, for active pharmaceutical ingredient manufactured in the country; (v) the first three (3) petitions for an unpublished generic drug for each input active pharmaceutical or association and pharmaceutical form, from different economic groups; (vi) medication included in the list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).

The maximum timeframes for ANVISA to make a final decision regarding pre-market approvals for drugs are set by Law 13.411/2016: 120 days from the submission date of the prioritization request, for drugs in the prioritized category; and 365 days from the submission date of the request, for drugs in the ordinary category. The aforementioned timeframes may be extended by a maximum of a third.