Abstract
The present situation in lengthy waiting time for the analysis of petitions drug
registration in Brazil reflects the need for change and adaptation to new demands and economic progress of the country. The rationalization of the analyzes of petitions for registration of medicines is a feature described by RDC Resolution No. 28/2007, which promotes huge gains in health as your goal meets the determinations of the National Drug Policy and the National Policy on Care Pharmaceuticals. In this context, this paper highlights the differences between the major advances in the area of regulation of drug registration in Brazil, compared to the many challenges and opportunities for improvement that still accompany its adaptation to the current reality of the country. We highlight the possibilities of innovations that should emerge in updating the RDC Resolution No. 28/2007.
registration in Brazil reflects the need for change and adaptation to new demands and economic progress of the country. The rationalization of the analyzes of petitions for registration of medicines is a feature described by RDC Resolution No. 28/2007, which promotes huge gains in health as your goal meets the determinations of the National Drug Policy and the National Policy on Care Pharmaceuticals. In this context, this paper highlights the differences between the major advances in the area of regulation of drug registration in Brazil, compared to the many challenges and opportunities for improvement that still accompany its adaptation to the current reality of the country. We highlight the possibilities of innovations that should emerge in updating the RDC Resolution No. 28/2007.
Translated title of the contribution | Drug Registration: Prioritizing Analysis and Innovation Opportunities. |
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Original language | Portuguese |
No. | 2357-8173 |
Specialist publication | Revista acadêmica - Oswaldo Cruz |
Publication status | Published - 1 Jun 2012 |
Keywords
- pharmaceuticals industries
- regulatory affairs
- regulatory science
- medicines