REGIONAL HARMONIZATION OF REGULATORY STANDARDS Sample Clauses

REGIONAL HARMONIZATION OF REGULATORY STANDARDS. One of the primary factors impeding a quicker introduction of both first and second line ARVs in develop- ing countries is the differing standards of various countries before the granting of marketing approval. A recent attempt by a generic company (with FDA approval) to export ARVs to Ethiopia, Nigeria, Tanzania and Uganda failed because the generic company’s products were not included on the WHO’s pre-quali- fication list. There have been recent initiatives within the SADC region to harmonize standards that must be complied with before marketing approval is granted. Such initiatives must be strongly supported and built on in order to facilitate the introduction of new ARVs by generic companies.
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