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[Historical evolution of package inserts in Brazil].
Telma Rodrigues Caldeira1, Eugênio Rodrigo Zimmer Neves, Edson Perini
1Agência Nacional de Vigilância Sanitária, Brasília, Brazil. telma.caldeira@anvisa.gov.br
Cadernos De Saude Publica
|April 9, 2008
Summary
Brazilian pharmaceutical package inserts evolved significantly, with more mandatory information added over time. However, full standardization for medicines with identical active ingredients was not achieved despite regulatory efforts.
Area of Science:
- Pharmaceutical Regulation
- Health Policy Analysis
- History of Medicine
Context:
- Package inserts are crucial for pharmaceutical information in Brazil.
- The study examines the evolution of these inserts within the Brazilian context.
- Key influencing factors include scientific research, globalization, and health policies.
Purpose:
- To analyze the historical evolution of pharmaceutical package inserts in Brazil.
- To assess the impact of scientific development, information globalization, and health policies on this evolution.
- To evaluate the success of regulatory efforts in standardizing information.
Summary:
- The study reviewed Brazilian health legislation from 1920 onwards, including the creation of the National Public Health Department.
- Analysis involved retrospective review of legislation and searches in legal databases like VISALEGIS.
- Package inserts saw significant regulatory changes and increased mandatory content from 1946 to 2006.
Impact:
- Package inserts became a vital information source in Brazil.
- Despite increased detail, standardization of information for drugs with the same active ingredient was not achieved.
- Highlights the ongoing challenges in pharmaceutical information regulation and standardization.
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