On May 8, 2026, the Ministry of Health published the Ordinance establishing the National Clinical Research Program (PPClin), designed to modernize the regulatory procedures for health scientific trials in Brazil.

The objective of the government program is to increase the country's attractiveness to the international biotechnology industry, boosting the ecosystem for the development of drugs, immunizing agents, and medical devices.

What is PPClin and what are its objectives

PPClin functions as an integration platform among hospital centers, universities, pharmaceutical laboratories, and health and ethical regulatory bodies.

The program guidelines prioritize the streamlining of trial approval workflows, encouraging cooperation between the National Research Ethics Body (Inaep), ANVISA, and the regional coordination offices for clinical studies.

In this way, the goal is to reduce the average authorization time for new trials, which currently represents an obstacle to the country's competitiveness in the global health innovation market.

Execution mechanisms and selection criteria

The promotion of research will be enabled through public calls, notices, and cooperation between entities in the innovation sector. Finep and CNPq will act in the structuring and capital support for the approved projects.

The eligibility criteria for centers and studies encompass:

• Alignment of research with the strategic demands of the SUS;
• Robustness of the installed infrastructure and analytical capacity of the centers;
• Prior experience of the team and investigators in conducting trials; and
• Integrated operation of a permanent local Research Ethics Committee (REC).

   

The economic potential of clinical research in the country

Data from Interfarma show that the clinical trials sector generates approximately R$ 6.3 billion annually in Brazil. Despite these impressive figures, it is estimated that the national infrastructure operates well below capacity.

The federal program aims to fill this gap, generating direct therapeutic benefits for local patients and putting Brazil on the map for cutting-edge clinical trials of highly complex drugs.

What changes for sponsors and investigators

Although the program does not summarily alter ethical and sanitary legislation, it establishes public commitments to administrative simplification and acceleration in the regulatory flow of protocol evaluation.

International sponsors must monitor the publication of the new PPClin calls for proposals to structure local partnerships with the certified centers of excellence.

PPClin and clinical research in Brazil: what companies and investigators need to know