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  • 1
    Online Resource
    Online Resource
    Comparative study of Regulatory requirements of Drug Product in Emerging market
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 3 ( 2019-09-15), p. 48-62
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 3 ( 2019-09-15), p. 48-62
    Abstract: Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v7i3.350
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2019
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 2
    Online Resource
    Online Resource
    DRUG PRODUCT REGISTRATION IN SEMI-REGULATED MARKET
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 2 ( 2018-02-06), p. 1-6
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 2 ( 2018-02-06), p. 1-6
    Abstract: There found a diversity of regulatory requirement in Semi regulated market. This region consists of mainly thecountries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacificand Gulf have somewhat harmonized their regulatory environment through The Association of Southeast AsianNations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonizedregulations in their respective regions.The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care,research & development and to meet the public requirement for safe and efficacious treatments to patient in need.ICH committee has given priority to harmonize the format of reporting data for quality, safety and Efficacy in theapplication dossier.The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keepup-to-date with the latest regulatory developments to ensure their place on the ROW market.This paper favors the regulatory processes for gaining marketing authorization in ROW countries in terms oftechnical data requirement for the dossier. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i2.3
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 3
    Online Resource
    Online Resource
    COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL
    Society of Pharmaceutical Tecnocrats ; 2016
    In:  International Journal of Drug Regulatory Affairs Vol. 4, No. 2 ( 2016-06-06), p. 1-9
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 4, No. 2 ( 2016-06-06), p. 1-9
    Abstract: This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v4i2.14
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2016
    detail.hit.zdb_id: 2738279-5
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  • 4
    Online Resource
    Online Resource
    DRUG APPROVAL PROCESS: A CONTRASTIVE APPROACH
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 2 ( 2018-02-11), p. 11-19
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 2 ( 2018-02-11), p. 11-19
    Abstract: The drug approval process is the vehicle through which drug sponsors formally approve a new pharmaceutical for sale and marketing. The goals of the approval process are to provide enough information about the drug safety and efficacy in human beings.  Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. The approval process starts with preclinical testing. For drugs that appear safe, an investigational new drug application (IND) is filed. If approved, clinical trials begin with phase 1 study that focus on safety and pharmacology. Phase 2 studies examine the effectiveness of the compound. Phase 3 is the final step before submitting a new drug application to the authority. A New Drug Application (NDA) contains all the information obtained during all phases of testing. Phase 4 studies, or post-marketing studies, are conducted after a product is approved.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i2.107
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 5
    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
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  • 6
    Online Resource
    Online Resource
    HARMONIZATION & ADVANCEMENT IN PHARMACEUTICAL INDUSTRY
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 2 ( 2018-02-06), p. 7-10
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 2 ( 2018-02-06), p. 7-10
    Abstract: The urgent requirement to rationalize and harmonize regulation was impelled by instance of rising cost of Healthcare, Research and Development and need to meet the public requirement to approach for the safe and efficacioustreatments to patient in need. ICH committee has given priority to harmonize the format of reporting data for quality,safety and Efficacy in the application dossier.ICH also provides different Guidelines under the topic Quality, Safety, Efficacy and Multidisciplinary to control thequality safety and efficacy of Pharmaceutical and Biotechnological products.For the dossier application part CTD provides harmonized format for product application. Earlier all the submissionssent to regulatory authorities in CTD, Paper format but it was a tedious job requiring lot of Time to review,documentation and paper work.Due to the advancement in Information technology, regulatory authorities from regulated countries throughout theglobe started to accept data in electronic format either in eCTD (Electronic common technical document)/ NeeS (NoneCTD electronic submission).The eCTD was developed subsequently by the ICH M2 Expert working group and allows for the electronicsubmission of the CTD from the applicant to regulator and provides harmonized technical solution for CTDelectronically. Many regulatory authorities completely eliminated the Paper submission and made eCTD mandatory.This is the centralized approach, saves time, cost, facilitate review process and greater transparency can be achievedvia central processing of submissions.Harmonization can also be seen in IPR stream by treaties and conventions. These international treaties andconventions contribute to the process of harmonization of patent laws.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i2.4
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 7
    Online Resource
    Online Resource
    PATENT V/S MONOPOLY-A CASE STUDY
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 2 ( 2018-02-11), p. 59-60
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 2 ( 2018-02-11), p. 59-60
    Abstract: Provisions of Compulsory License balance this law between interest of Inventor & public as through these provisions License can be provided to others if the invention did not use sufficiently for Public. In case of medicine this law remains in debate from its beginning as Drugs are essential & Life saving commodities & monopoly on drugs products can make them inaccessible to poor people. Big Pharma players tries to extend monopoly on their patented products through subsequently filling frivolous Patents as report says that most of the Patents filed remain as minor modifications than any breakthrough invention. This practice doesn’t provide more new Drugs molecules which can help in fighting new form of disease, through this practice Pharma companies only tries to increase their profits.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i2.111
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 8
    Online Resource
    Online Resource
    PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION
    Society of Pharmaceutical Tecnocrats ; 2017
    In:  International Journal of Drug Regulatory Affairs Vol. 5, No. 2 ( 2017-06-21), p. 1-12
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 5, No. 2 ( 2017-06-21), p. 1-12
    Type of Medium: Online Resource
    ISSN: 2321-6794
    URL: Article
    DOI: 10.22270/ijdra.v5i2.196
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2017
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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