Discussion on the main review and evaluation points of the consistency of quality and efficacy of topical vaginal preparations / 中国药学杂志

ABSTRACT

Topical vaginal preparations are administered via vaginal channels to play a local role. This paper discussed review points of vaginal generic drugs in order to provide references for research and review of this drugs in china. METHODS By literature research, the paper collected the approval information and the pharmacopoeia record information of the USA, the EU, the JP and the China, discussed the review points of vaginal generic drugs in combination with the review requests of FDA and EMA, and analyzed the technical points of the quality and efficacy of vaginal generic drugs. RESULTS AND CONCLUSION S The pharmacy researches on vaginal generic drugs should focus on the rationality of prescription, process and critical quality attribute researches, concerned the consistence of inter-batch and reference listed drug. FDA and EMA usually review the equivalence of efficacy and safety with clinical trials which often need a great deal of volunteers.