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  • 1
    Online Resource
    Online Resource
    OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 1 ( 2013-02-05), p. 1-4
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 1 ( 2013-02-05), p. 1-4
    Abstract: Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceuticalindustries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized variousindustries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a veryspecific meaning within the pharmaceutical industries.DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionalsare dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.RA as profession is broader than registration of products, they advise companies both strategically and technically at thehighest level. Their role begins right from development of a product to making, marketing and post marketing.Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientificthinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are alsoplaced upon the claims which can be made for the product on labeling or in advertising.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i1.1
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2013
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 2
    Online Resource
    Online Resource
    Comparative study of Regulatory requirements of Drug Product in Emerging market
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 1 ( 2022-03-15), p. 51-82
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 1 ( 2022-03-15), p. 51-82
    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.v10i1.510
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 3
    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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  • 4
    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
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  • 5
    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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  • 6
    Online Resource
    Online Resource
    MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 3 ( 2013-10-31), p. 1-6
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 3 ( 2013-10-31), p. 1-6
    Abstract: Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i3.5
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2013
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 7
    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
    SSG: 15,3
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  • 8
    Online Resource
    Online Resource
    A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA
    Society of Pharmaceutical Tecnocrats ; 2014
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 1 ( 2014-03-06), p. 1-11
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 1 ( 2014-03-06), p. 1-11
    Abstract: Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. 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. This article focuses on drug approval process in different countries like USA, Europe and India. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i1.7
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2014
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 9
    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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  • 10
    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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