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Regulation of Advanced Therapy Medicinal Products: Concept Note and Recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, October 2018)

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English; 19 pages (320.6Kb)
Date
2019-09-20
Document Number
PAHO/HSS/19-004
Author
Pan American Health Organization
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Abstract
The aim of this document is to highlight the progress made with regard to advanced therapy products, the risks associated with such products, and the regulatory challenges they pose for Member States with a view to strengthening regulatory systems. The document is also a call to action for governments to consider the development of standards and rules for regulating these products in order to control the use of unapproved therapies and prevent risks to the population. As discussed, there are cross-cutting regulatory principles that should be implemented by any regulatory body that plans to undertake the regulation and oversight of advanced therapy products.
Subject
Pharmaceutical Services; Health Systems; Pharmacy; Pharmacovigilance; Hematopoietic Stem Cells; Immune System; Hemic and Immune Systems
Category of PAHO Strategic Plan 2014-2019
Cat 4. Health Systems
URI
https://iris.paho.org/handle/10665.2/51558
Citation
Pan American Health Organization. Regulation of Advanced Therapy Medicinal Products: Concept Note and Recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, October 2018). Washington, D.C.: PAHO; 2019.
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  • General Publications / Publicaciones Generales

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Pan American Health Organization
World Health Organization. Regional Office for the Americas
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