Introduction of the WHO prequalification of medicines programme and comparator product
CHEN Jie
YANG Dong-sheng
NIU Jian-zhao
Abstract：The development history and concerned pharmaceutical product filed scope of the " WHO prequalification of medicines programme",are described in this paper,as well as detailed elaboration of the prequalification procedure in five steps:submission of the expressions of interest,screening and acceptance of the expressions of interest,assessment of dossiers and site inspection,final decision on prequalification,and listing of prequalified product.The statistics and analysis of the status of domestic pharmaceutical manufacturing enterprises who have already been prequalified in the prequalification of medicines programme are also provided.At the same time,the definition and development history of the comparator product used in the prequalification programme is also introduced as well as the source and purchase of the comparator product.And the introduction to the system of "WHO prequalification of medicines programme" and its comparator product,has a vital influence and guiding significance to promote the domestic pharmaceutical products to the international market.
Keywords：WHO prequalification of medicines programmecomparator productInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)multisource (generic) pharmaceutical products
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2928-2932 )