Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan.

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  • Additional Information
    • Publication Year:
      2019
    • Subject Terms:
    • Author-Supplied Keywords:
      Article 38–1
      Article 38–2
      Certificate of Pharmaceutical Product
      Clinical study
      Regulation reform
      Submission lag
    • NAICS/Industry Codes:
      NAICS/Industry Codes 325414 Biological Product (except Diagnostic) Manufacturing
    • Abstract:
      Summary: Drug lag, which delays patients' access to medicinal products, is typically associated with pharmaceutical regulations. To shorten drug lag, health authorities may establish new policies to liberalize the regulations, a step that is important in countries, such as Taiwan, with consumer demand for imported novel therapeutic agents. Taiwan's government enacted Articles 38–1 and 38–2 of Regulations for Registration of Medicinal Products to relax the regulatory barriers for new drug submission, thus conditionally exempting the requirement for the Certificate of Pharmaceutical Product (CPP). This study examined whether the enacted regulations reduce submission lag by analyzing the time gap of submission between Taiwan and the United States during 2014–2017. The results indicated that the enacted regulations substantially affected submission lag. Submission lag was significantly shorter for applications not requiring a CPP than those requiring one CPP, which in turn was significantly shorter than those requiring two CPPs. This conclusion can be applied to biological, chemical, non-orphan, and oncology drugs and also applications filed by subsidiary companies, but not orphan drugs and applications filed by contract agents. Among applications requiring one CPP, oncology drugs showed the shortest submission lag. Certain factors, such as clinical studies recruiting over-threshold Taiwanese participants and those performed before the submission of new drug application in the United States, may shorten submission lag. In summary, this study justifies the policy of the exemption from CPP requirements, which supports the hypothesis that relaxing regulatory barriers can reduce submission lag in Taiwan. [ABSTRACT FROM AUTHOR]
    • Abstract:
      Copyright of Investigational New Drugs is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
    • ISSN:
      01676997
    • Accession Number:
      138543857
  • Citations
    • ABNT:
      SUN, I.-C. Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan. Investigational New Drugs, [s. l.], v. 37, n. 5, p. 1094, 2019. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edb&AN=138543857. Acesso em: 24 nov. 2020.
    • AMA:
      Sun I-C. Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan. Investigational New Drugs. 2019;37(5):1094. Accessed November 24, 2020. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edb&AN=138543857
    • APA:
      Sun, I.-C. (2019). Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan. Investigational New Drugs, 37(5), 1094.
    • Chicago/Turabian: Author-Date:
      Sun, I-Chen. 2019. “Significant Differences on Submission Lag Following Regulation Reform for Registration of Novel Therapeutic Drugs in Taiwan.” Investigational New Drugs 37 (5): 1094. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edb&AN=138543857.
    • Harvard:
      Sun, I.-C. (2019) ‘Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan’, Investigational New Drugs, 37(5), p. 1094. Available at: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edb&AN=138543857 (Accessed: 24 November 2020).
    • Harvard: Australian:
      Sun, I-C 2019, ‘Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan’, Investigational New Drugs, vol. 37, no. 5, p. 1094, viewed 24 November 2020, .
    • MLA:
      Sun, I.Chen. “Significant Differences on Submission Lag Following Regulation Reform for Registration of Novel Therapeutic Drugs in Taiwan.” Investigational New Drugs, vol. 37, no. 5, Oct. 2019, p. 1094. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edb&AN=138543857.
    • Chicago/Turabian: Humanities:
      Sun, I-Chen. “Significant Differences on Submission Lag Following Regulation Reform for Registration of Novel Therapeutic Drugs in Taiwan.” Investigational New Drugs 37, no. 5 (October 2019): 1094. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edb&AN=138543857.
    • Vancouver/ICMJE:
      Sun I-C. Significant differences on submission lag following regulation reform for registration of novel therapeutic drugs in Taiwan. Investigational New Drugs [Internet]. 2019 Oct [cited 2020 Nov 24];37(5):1094. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edb&AN=138543857