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      Evolution of the registration regulations for proprietary Chinese medicines in China

      , 1 , 1 , 1

      Chinese Journal of Natural Medicines

      Elsevier

      Registration, Proprietary Chinese Medicine, China

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          Abstract

          In this review, we provide a comprehensive overview on the registration of proprietary Chinese medicines (PCMs) in China over the past century by examining published literature and historical data. We will examine this evolving administrative practice for PCMs registration in China, which is divided to the following five stages: (1) initial measures (1915–1948); (2) early development (1949–1965); (3) provincial approval and trial implementation of the “approval number” system (1966–1984); (4) legislation and cleanup (1985–1999); and (5) centralized national approval (2000 until now), offering a panoramic view on the characteristics of PCMs registration management in China.

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          Author and article information

          Journal
          CJNM
          Chinese Journal of Natural Medicines
          Elsevier
          1875-5364
          20 January 2017
          : 15
          : 1
          : 4-11
          Affiliations
          1School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
          Author notes
          *Corresponding author: YUAN Lin, Tel:86-10-88330826, 88363240; Fax:86-10-68315648, E-mail: yuanlin@ 123456cfda.gov.cn

          These authors have no conflict of interest to declare.

          Article
          S1875-5364(17)30003-1
          10.1016/S1875-5364(17)30003-1
          Copyright © 2017 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

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