[Blood regulation in Brazil: contextualization for improvement]

Area of Science:

• Public Health
• Regulatory Science
• Hematology

Background:

• Blood products are essential medicines with inherent transfusion risks.
• Governmental regulatory action is crucial for blood product quality and safety.
• Regulatory agencies ensure blood component production adheres to operating rules.

Purpose of the Study:

• To discuss the current Brazilian blood regulatory model.
• To identify challenges and areas for improvement in blood safety regulations.
• To analyze the evolution of Brazil's national blood policy.

Main Methods:

• Review of Brazil's national blood policy and regulatory framework.
• Analysis of the inclusion of Good Manufacturing Practices (GMP).
• Examination of state-coordinated policies and national surveillance systems.

Main Results:

• Brazil has advanced its regulatory model by adopting GMP, aligning with WHO recommendations.
• Blood facilities are increasingly viewed as manufacturing centers for blood-derived biologics.
• Enhanced safety mechanisms for donors and recipients have been strengthened.

Conclusions:

• A State-coordinated national blood policy and robust surveillance are vital for ensuring blood supply.
• Brazil's regulatory model has improved but faces ongoing challenges for further enhancement.
• Continuous improvement is necessary to manage sanitary risks in blood processing and use.