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  • 1
    Online Resource
    Online Resource
    A comparative evaluation of Regulatory requirements for Registration of Dietary Supplements in Brazil, Russia, India, China and South Africa
    Society of Pharmaceutical Tecnocrats ; 2023
    In:  International Journal of Drug Regulatory Affairs Vol. 11, No. 3 ( 2023-09-19), p. 53-61
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 3 ( 2023-09-19), p. 53-61
    Abstract: Nutraceuticals are products that are rich in nutrients and provide health benefits, because of many factors like lifestyle changes and change in the dietary habits of people now a day, these products are widely used. Among all the other categories of Nutraceuticals Dietary supplement comprises huge part of Nutraceuticals. They are distinguishable from conventional food or drugs. They are intended to use to supplement the normal diet. The terms, nomenclature and definitions of the dietary supplements vary throughout the world. Different countries have their own regulation and legislative requirements. In regulated countries streamlined regulations are there, while well-structured and streamlined regulations for Nutraceuticals are lacking in other countries. In developing and emerging nations the regulation of dietary supplements are constantly evolving. It is necessary that the product complies all the regulatory requirements before they are placed on the market. The proposed study is based on the regulation and legislative requirements of dietary supplements in Brazil, Russia, India and South Africa.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v11i3.616
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2023
    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
    Similarities and differences in filing for Drug Master File in US, Canada and Europe
    Society of Pharmaceutical Tecnocrats ; 2023
    In:  International Journal of Drug Regulatory Affairs Vol. 11, No. 3 ( 2023-09-19), p. 33-38
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 3 ( 2023-09-19), p. 33-38
    Abstract: Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the applicable authority in the intended drug market. The document provides the non-supervisory authority with confidential, detailed information about installations, processes, or papers used in the manufacturing, processing, packaging, and storing of one or further mortal drugs. The DMF form allows an establishment to cover its intellectual property from its mate while complying with non-supervisory conditions for exposure of processing details. There is no non-supervisory demand to file a DMF. Drug Master Files (DMF) is a document containing complete information on an Active Pharmaceutical element (API) or finished drug capsule form. Though there are no non-supervisory conditions to file a DMF, the benefit of its use is inviting. A drug Master Files (DMF) is an voluntary non-supervisory submission and is submitted at the discretion of the DMF holder to help their guests. A DMF is NOT a cover for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. An Active Substance Master File (ASMF) is the presently honored term in Europe, formerly known as European drug Master file (eDMF) or a US- Drug Master File( US- DMF) in the United States.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v11i3.613
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2023
    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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