Brasília – Anvisa published two new regulatory acts establishing temporary measures to speed up the assessment of clinical-research submissions and of registration and post-registration dossiers for medicines and biological products. The resolutions, approved by the Board of Directors on 7 November and published on 10 November, introduce exceptional mechanisms such as grouped analysis of similar petitions, dedicated priority queues, reliance-based fast-track channels, and Exceptional Assessment Management Plans (PGA Excepcional) aimed at reducing regulatory backlog and improving workflow efficiency.

The new resolution (RDC 997/2025) also redefines the concept of regulatory backlog and authorizes abbreviated or verified technical reviews for synthetic and biological medicines. Companies may submit a single amendment to address high-risk issues until 7 December 2025, while GGMED must publish detailed procedures for the new evaluation model by 7 January 2026. Additional tools include voluntary queue-position swaps within the same company and formal transparency requirements for any chronological reordering of processes.

A second act (Ordinance 2.012/2025) establishes the Health Innovation Regulatory Monitoring Committee, responsible for coordinating the review of strategic innovative technologies. The committee will track up to five products simultaneously — including advanced therapies, novel medicines, innovative vaccines, digital-health solutions and AI-based technologies — with the ability to expand this number depending on operational capacity. It will apply agile-regulation tools, promote cross-directorate coordination, and identify scientific and regulatory gaps to support timely decision-making.

Source: NK Consultores

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