ANVISA Publishes Exceptional Rule to Expedite Analysis of Medicines and Biological Products

The National Health Surveillance Agency (Anvisa) published on Monday, November 10, 2025, the Collegiate Board Resolution (RDC) No. 997/2025, which institutes exceptional measures to optimize the queue for analysis of clinical trial consent, registration, and post-registration of medicines and biological products.

The initiative is essentially aimed at reducing the accumulated regulatory backlog and increasing the efficiency of the Agency’s evaluation processes.

The new rule establishes that petitions for clinical trial consent, registration, and post-registration of medicines and biological products that meet criteria such as Reliance (utilization of evaluations from other regulatory authorities), priority, and the Assessment Management Plan (PGA) will be allocated to a specific queue.

In this regard, the Exceptional PGA was created, characterized as a temporary instrument that allows the grouping of processes and the definition of a non-chronological analysis order, provided it is justified, and applicable to medicines and biological products.

Furthermore, the RDC allows for another grouping of processes when the petitions exhibit technical, ownership, or input similarity.

One of the Resolution’s measures is also the possibility of substituting the queue position between registration processes or the inclusion of a new concentration, provided they belong to the same company:

• The substitution is only permitted upon formal withdrawal of the original process.
• It must be requested within specific criteria of the RDC, with a deadline of November 25, 2025.
• Substitution is prohibited for processes already classified as prioritized.
• It is important to emphasize that the withdrawal of the process implies the waiver of the refund of the inspection fee paid.

The exceptional measures provided in this Resolution will be applicable only to petitions protocolled up to the date of the RDC’s publication, not covering new protocols.

This measure, as stated by Anvisa’s Director Daniel Pereira himself, is grounded in the growth of the regulatory backlog and aims to diminish the impacts on public health arising from analysis delays.

For more information on the content of this newsletter, feel free to contact:  Viviane Trojan viviane.trojan@kasznarleonardos.com and Giovanna Verginelli Mezher giovanna.mezher@kasznarleonardos.com.