rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Approaching China's Pharmaceutical Market
    sub title: A Fundamental Guide to Clinical Drug Development
  name:
    name part: Lu, Ming Q.
    role:
      role term: editor.
  name:
    name part: SpringerLink (Online service)
  type of resource: text
  origin info:
    place:
      place term: gw
    date issued: 2015
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: electronic
    form: electronic resource
    reformatting quality: access
    form: remote
    extent: XVI, 648 p. 54 illus., 38 illus. in color. online resource.
  abstract: This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)—including its regulations and registration procedures—and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China’s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.
  table of contents: Preface -- Law, Regulation and Guidance -- Pharmaceutical Intellectual Property Rights in China -- The China Food and Drug Administration (CFDA) -- Registration -- Guidance for Application Materials/Booklets (Chemical) -- New Investigational Drug Application -- Clinical Development of Investigational New Drug -- Strategic Drug Development in China and Surrounding Countries -- Drug Safety Monitoring and Reporting Systems in China -- In Vitro Diagnostic Development -- Index.
  note: edited by Ming Q. Lu.
  subject:
    topic: Medicine
  subject:
    topic: Pharmaceutical technology
  subject:
    topic: Biomedicine
  subject:
    topic: Pharmaceutical Sciences/Technology
  classification: RS380
  classification: RS190-210
  classification: 615.19
  related item:
    title info:
      title: Springer eBooks
  identifier: 9783319155760
  identifier: http://dx.doi.org/10.1007/978-3-319-15576-0
  record info:
    record creation date: 150730
    record change date: 20150730165009.0
    record identifier: 978-3-319-15576-0