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  • Badjatya, Jitendra Kumar  (2)
  • Pooja Chaudhari  (2)
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  • Badjatya, Jitendra Kumar  (2)
  • Pooja Chaudhari  (2)
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  • 1
    Online Resource
    Online Resource
    Current Regulatory requirements for registration of nutraceuticals in ASEAN
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 4 ( 2021-12-28), p. 37-45
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 4 ( 2021-12-28), p. 37-45
    Abstract: Nutraceuticals are bioactive or natural chemical components that are been marketed all over the world. It claims to be disease preventing along with health promoting product with some of the medicinal properties. It is categorized as vitamin, mineral, animal product and health supplement. Nutraceuticals has the major advantage over the medicines as they avoid the adverse effects that are caused by drugs. Nutraceutical market is expanding day by day and the claim for the product is enlarging. Users are looking for alternatives for the prescribed medicines as well as the health product that will supplement dietary intake on daily basis. Different countries classified products into various categories depending upon their health claim. In Association of South East Asian Nations (ASEAN) the Asian Alliance of Health Supplement Association (AAHSA) regulates the responsibilities to ensure that the nutraceuticals before marketing are safe.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v9i4.501
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2021
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Good Practices in Management of deficiencies in CTD dossier and comparative study for US, EU and Australia
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 4 ( 2019-12-18), p. 40-55
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 4 ( 2019-12-18), p. 40-55
    Abstract: This topic aims at reviewing the drug and drug product filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for the regulation of food and drug product in Europe. TGA is the Regulatory Agency which is responsible for the regulation of therapeutic goods in Australia. A dossier contains detail information about the drug substance and drug product and result of studies that are carried out in development process. For getting market authorization has to be submitted to the respective regulation bodies. Due to various regulations, ICH introduced CTD for such countries that come under it. CTD is critical for dossier submission. For regulatory submission that is to be accepted in all ICH countries. CTD provides standardized structure. CTD makes filing easier globally. But there are differences in dossier submission requirements in these countries i.e. Module I is country specific and other regional guideline are also considered while compiling dossier application.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v7i4.371
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2019
    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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