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  • R., Suthakaran  (3)
  • 2015-2019  (3)
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  • 2015-2019  (3)
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  • 1
    Online Resource
    Online Resource
    AN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 3 ( 2018-02-12), p. 14-18
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 3 ( 2018-02-12), p. 14-18
    Abstract: The Drug regulatory authority of China was renewed from state pharmaceutical administration of China (SPAC) to state food and Drug administration (SFDA) with the announcement and declaration of Chinese ministry of health, the established regulatory standards of SFDA were keen to keep with international standards of EU, Japan and USA, the Drug registrations and Drug approvals are carried with established affiliated units for fast track evaluation within prescribed period ordered by SFDA, the state food and Drug administration is developed stringently and modified its standards according to the US healthcare regulatory system, in this review the permanently keeping standards of regulatory functions were detailed, and the untiring responsibilities of affiliated units of SFDA were to be recognized where their performance was a key aspect.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i3.137
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 2
    Online Resource
    Online Resource
    EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2018-02-12), p. 21-25
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2018-02-12), p. 21-25
    Abstract: Pharmaceutical drug development had become very costly and time consuming. There is an estimate that a drug from molecular development to marketing approvals cost $800 Millions. Drug approval process is time consuming process most companies loss their patent exclusivity before drug gets marketing approvals. To prevent innovators from monetary losses occurred in drug development and to encourage innovation US FDA and EMEA introduced exclusivities under various categories.  Within the period of drug exclusivity no application is accepted either ANDA or 505 (b) (2).
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.128
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    INDONESIAN PATENT SYSTEM: AN OVERVIEW
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2018-02-12), p. 26-30
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2018-02-12), p. 26-30
    Abstract: Intellectual property protection is a one type of protection to the innovator from their creative efforts. On November 1, 1991, the Indonesian Parliament passed Law No. 6/1989 on Patents. The new law came into effect on August 1, 1991. The patenting system in Indonesia is discussed using some recent statistics and their fees, patent exclusivity, litigation, grace period. As of 1989, there have been over 13,000 applications for temporary patent registration, 96% of which were of foreign origins. None of the applications were denied, were ever granted because no patent Law existed. In this paper discussed brief introduction about Indonesia patent system.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.129
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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