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The paradigm shift from Stringent Regulatory Authorities to WHO-Listed Authorities
1Paris, France.
Abstract:
Regulatory systems play a key role in assuring the quality, safety, and efficacy of health products. After more than 20 years of efforts on regulatory capacity improvement of the less-equipped National Regulatory Authorities, the transition from the concept of Stringent Regulatory Authorities (SRAs) to WHO-Listed Authorities (WLAs) represents a significant paradigm shift in global health ecosystem. This review aims to provide a better understanding of this evolution and to clarify the WLA concept, as a component for the long-term success of this framework.
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