Snapshot

The Priority Clasification for Review, Post Auth, Clinical Trial Auth and GMP: nº 1.001, de 11/12/2025 (incl orphans) pathway has been developed by the of Brazil.

This pathway can be used where I – therapeutic alternative: medicines that contain different active pharmaceutical ingredients indicated for the same therapeutic or clinical objective; II - serious debilitating condition: disease or condition associated with irreversible morbidity or a high probability of death, unless the course of the disease is interrupted; III – emerging or reemerging diseases: new conditions of the state of health, generally of infectious origin, or already known conditions that acquire or reacquire epidemiological significance in public health; IV – rare disease: that which affects up to sixty-five people out of every hundred thousand individuals, as defined by the National Policy for Comprehensive Care for People with Rare Diseases, based on official national data or, when non-existent, on data published in technical-scientific documentation; V – neglected diseases: diseases that mainly affect the poorest populations and those with limited access to health services, and do not present economic attractions for the development of medicines and drugs; VI – Clinical Drug Development Dossier (DDCM): compiled of documents to be submitted to Anvisa for the purpose of evaluating the steps inherent to the development of an experimental drug in order to obtain information to support the registration or post-registration changes of said product; VII – Specific Clinical Trial Dossier (DEEC): compiled of documents to be submitted to Anvisa for the purpose of obtaining information regarding clinical trials, to be conducted in Brazil, which are part of the Experimental Drug Development Plan; VIII – Public Health Emergency: a situation that requires the urgent use of measures to prevent, control and contain risks, damages and aggravations to public health, related to epidemiological circumstances (outbreaks and epidemics), disasters, or lack of assistance to the population; IX – medicine: pharmaceutical product, technically obtained or elaborated, for prophylactic, curative, palliative or diagnostic purposes; X – novel biosimilar drug: the first biological drug to be registered in the country by the comparability route, which corresponds to a certain active pharmaceutical ingredient or association; XI – novel generic drug: corresponds to the first generic drug for sale under medical prescription to be registered in the country, for a given active pharmaceutical ingredient or association, concentration and pharmaceutical form; XII – significant improvement in efficacy or safety: when the drug presents a better efficacy or safety profile demonstrated by clinical outcome, compared to the existing therapeutic alternative; XIII – Productive Development Partnership (PDP): partnerships that involve cooperation through agreements between public institutions and between public institutions and private entities for the development, transfer and absorption of technology, production, productive and technological training of the country in strategic products to meet the demands of the SUS; XIV – Local Development and Innovation Program (PDIL): a program established with the purpose of promoting the development of local production and innovation focused on health challenges, the sustainability and resilience of the Unified Health System (SUS), and the expansion of access to health, in order to reduce the productive and technological vulnerability of the SUS; e XV – simplified primary petition: petition linked to a primary petition in which the applicant requests the granting of registration of a drug or biological product, through the simplified procedure; and must have the same pharmaceutical form(s), concentration(s) and presentation(s) as the primary petition matrix. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Art. 12. O prazo para decisão final quanto à análise das petições de registro, pós- registro e de petições primárias de anuência prévia de DDCM e DEEC e de petições secundárias de modificações substanciais ao produto sob investigação e emendas substanciais ao protocolo clínico enquadradas como prioritárias será de: I - 120 (cento e vinte) dias para as petições de registro de medicamento; RET., 25/02/2026 - Seção 1 II - 60 (sessenta) dias para as petições de pós-registro; ou III - 60 (sessenta) dias para as petições primárias de anuência prévia de DDCM e DEEC e de petições secundárias de modificações ao produto sob investigação e emendas substanciais ao protocolo clínico. § 1º Os prazos serão contados a partir do protocolo da petição prioritária. § 2º No caso de solicitação de priorização após o protocolo da petição, os prazos serão contados a partir do protocolo do pedido de priorização. § 3º Para petições secundárias de modificações substanciais ao produto sob investigação e de emendas substanciais ao protocolo clínico, os prazos serão contados a partir do protocolo da petição secundária. § 4º As solicitações de esclarecimento ou exigências técnicas suspenderão a contagem dos prazos determinados neste artigo até que sejam atendidas. § 5º Os prazos mencionados nos incisos I, II e III deste artigo, poderão ser prorrogados por até um terço do prazo original, uma única vez, mediante decisão fundamentada expedida em, no mínimo, quinze dias úteis antes do término do prazo original. Article 12. The deadline for the final decision regarding the analysis of the petitions for registration, post-registration and primary petitions for prior consent of DDCM and DEEC and secondary petitions for substantial modifications to the product under investigation and substantial amendments to the clinical protocol classified as priorities will be: I - 120 (one hundred and twenty) days for petitions for registration of medicine; RET., 02/25/2026 - Section 1 II - 60 (sixty) days for post-registration petitions; or III - 60 (sixty) days for primary petitions for prior consent of DDCM and DEEC (Clinical Drug Development Dossier, DDCM, Clinical Trial Specific Dossier, DEEC) and secondary petitions for modifications to the product under investigation and substantial amendments to the clinical protocol. Paragraph 1 - The deadlines shall be counted from the filing of the priority petition. Paragraph 2 - In the case of a request for prioritization after the filing of the petition, the deadlines shall be counted from the filing of the request for prioritization. Paragraph 3 - For secondary petitions for substantial modifications to the product under investigation and substantial amendments to the clinical protocol, the deadlines shall be counted from the filing of the secondary petition. Paragraph 4 - Requests for clarification or technical requirements shall suspend the counting of the deadlines determined in this article until they are met. Paragraph 5 - The deadlines mentioned in items I, II and III of this article 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..