{"id":1172,"date":"2026-09-10T08:54:56","date_gmt":"2026-09-10T11:54:56","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&p=1172"},"modified":"2026-09-10T08:54:56","modified_gmt":"2026-09-10T11:54:56","slug":"rdc-997-2025-understanding-the-resolutions-impact-and-developments-in-anvisas-application-review","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/09\/10\/rdc-997-2025-understanding-the-resolutions-impact-and-developments-in-anvisas-application-review\/","title":{"rendered":"RDC 997\/2025: Understanding the Resolution’s Impact and Developments in ANVISA’s Application Review"},"content":{"rendered":"

In November 2025, ANVISA published Resolution RDC No. 997, of November 7, 2025, which governs the management of the review queue for prior consent in clinical research and for marketing authorization and post-authorization applications for medicinal products and biological products, in order to reduce the Agency’s regulatory backlog. The proposed measures aim for greater efficiency in the assessment processes.<\/span><\/p>\n

<\/p>\n

The rule has been in effect since its publication and will remain valid through December 31, 2026, a period during which several actions have been implemented and complemented by subsequent acts, making it essential to follow its developments.<\/span><\/p>\n

What RDC 997\/2025 establishes<\/h3>\n

The resolution is based on the concept of regulatory backlog, defined as the set of applications pending a technical decision whose legal deadline has expired or whose processing has exceeded reasonable duration parameters. These legal deadlines are those set out in Law No. 13,411, of December 28, 2016, which amended specific provisions of Law No. 6,360, of September 23, 1976, and established deadlines for the review and decision of applications submitted to ANVISA.<\/span><\/p>\n

To address this regulatory backlog, the rule creates mechanisms that speed up the review and issuance of opinions for applications within its scope. Among these mechanisms, the creation of specific queues stands out, which may follow an order different from the ordinary queues, based on priority or Reliance criteria.<\/span><\/p>\n

In addition, the rule institutes Exceptional Assessment Management Plans (<\/span>PGA Excepcional<\/span><\/i>, in Portuguese), which allow ANVISA to group technically similar processes, provided this is duly justified and previously approved by the Board of Directors (Dicol). Below are the main measures adopted by application category.<\/span><\/p>\n

Clinical Research<\/p>\n

Allocation to a specific queue for primary and secondary clinical research applications for medicinal products and biological products that meet <\/span>Reliance<\/span><\/i> criteria, in accordance with RDC 945\/2024 and Normative Instruction (IN) No. 289\/2024, filed through a specific amendment.<\/span><\/p>\n

Synthetic Medicinal Products<\/h3>\n