Starting October 5, 2026, new DDCTA authorization requests must use the new Solicita form and subject codes 12451 or 12452, depending on the developer’s origin. Previously filed processes will continue as usual.
The change is operational, but relevant to sponsors, research sites and companies developing advanced-therapy products in Brazil.
Regulatory and clinical-research teams need to update internal procedures, checklists and submission instructions. Although the change is administrative, using an incorrect subject code or an outdated workflow may lead to rework and delays.
On September 21, 2026, Anvisa announced that a new electronic form for submitting Clinical Development Dossiers for Advanced Therapy Products (DDCTAs) will be available in the Solicita system starting October 5. According to the Agency, the change is intended to better structure the information submitted and make process management and review more efficient.
The new workflow creates two subject codes for primary submissions: 12451 for international developers and 12452 for national developers. Once the new form takes effect, codes 12351, 12352, 12353 and 12354 will no longer be used for new DDCTA authorization requests.
Anvisa states that the change does not affect processes that have already been filed. For new dossiers, however, the Agency recommends that applicants review the completion instructions in advance and confirm the applicable code before submission.
Sponsors, national and international developers, CROs, research sites and regulatory-affairs teams involved in DDCTAs for advanced-therapy products.
Update internal submission workflows and checklists; use subject codes 12451 or 12452 according to the developer’s origin; and review the Solicita instructions before filing new submissions.
October 4, 2026
Anvisa
Identifier: Códigos de assunto 12451 e 12452
Accessed on September 24, 2026
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