The recent approval of the Clinical Research Act in Brazil marks a crucial step in the country’s advancement in the global scenario of drug and therapy development. However, for the Act to reach its full potential, it is essential that its regulation preserves the original spirit of the legislation, ensuring the stability of the system, predictability, and speed in regulatory assessments.
The Importance of Proper Regulation
The new law’s regulations must be drafted with the active participation of the regulated sector, ensuring that the sector’s challenges and needs are heard and considered. Stakeholder participation is essential to create a regulatory environment that is both robust and agile, capable of attracting investment and fostering scientific and technological development in Brazil.
Benchmarking and Learning from Industrialized Countries
By looking at more industrialized countries, it is possible to identify good practices that can be applied in the regulation of the new Brazilian law. Countries such as the United States, the United Kingdom and Germany have highly efficient clinical research systems, with clear and predictable regulatory processes. Benchmarking these nations can help Brazil structure regulations that promote not only the growth of the sector, but also investor confidence and global competitiveness.
Development Potential for Brazil
With effective regulation, Brazil can establish itself as a leading destination for clinical trials. The new law, if well implemented, can address current shortcomings, such as the country’s limited participation in global clinical trials (only 1.5% of the total). By ensuring faster and more predictable regulatory processes, Brazil can attract more foreign investment, increase its global participation, and boost the development of new therapies and medicines.
Conclusion
The regulation of the new Clinical Research Law is a unique opportunity for Brazil. By learning from international best practices and ensuring the inclusion of the regulated sector in the process, the country can create an environment conducive to the growth of the clinical research sector. In doing so, it will not only increase its participation in the global scenario, but also strengthen its economy and ensure better treatments for the population.
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