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  • 1
    Online Resource
    Online Resource
    ABC of Clinical Trials with the Mark of Safety, Efficacy and Transparency
    Bentham Science Publishers Ltd. ; 2017
    In:  Applied Clinical Research, Clinical Trials and Regulatory Affairs Vol. 4, No. 2 ( 2017-08-23)
    Details
    In: Applied Clinical Research, Clinical Trials and Regulatory Affairs, Bentham Science Publishers Ltd., Vol. 4, No. 2 ( 2017-08-23)
    Type of Medium: Online Resource
    ISSN: 2213-476X
    URL: Article
    DOI: 10.2174/2213476X04666170717103612
    Language: English
    Publisher: Bentham Science Publishers Ltd.
    Publication Date: 2017
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  • 2
    Online Resource
    Online Resource
    Regulatory Traits - Relevance to Contemporary Healthcare Environment (Part-I)
    Bentham Science Publishers Ltd. ; 2019
    In:  Applied Clinical Research, Clinical Trials and Regulatory Affairs Vol. 6, No. 1 ( 2019-03-27), p. 5-6
    Details
    In: Applied Clinical Research, Clinical Trials and Regulatory Affairs, Bentham Science Publishers Ltd., Vol. 6, No. 1 ( 2019-03-27), p. 5-6
    Type of Medium: Online Resource
    ISSN: 2213-476X
    URL: Article
    DOI: 10.2174/2213476X0601190306104750
    Language: English
    Publisher: Bentham Science Publishers Ltd.
    Publication Date: 2019
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  • 3
    Online Resource
    Online Resource
    Regulatory Traits - Relevance to Contemporary Healthcare Environment (Part-II)
    Bentham Science Publishers Ltd. ; 2019
    In:  Applied Clinical Research, Clinical Trials and Regulatory Affairs Vol. 6, No. 3 ( 2019-11-13), p. 161-162
    Details
    In: Applied Clinical Research, Clinical Trials and Regulatory Affairs, Bentham Science Publishers Ltd., Vol. 6, No. 3 ( 2019-11-13), p. 161-162
    Type of Medium: Online Resource
    ISSN: 2213-476X
    URL: Article
    DOI: 10.2174/2213476X0603191113153754
    Language: English
    Publisher: Bentham Science Publishers Ltd.
    Publication Date: 2019
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  • 4
    Online Resource
    Online Resource
    Strategic archetype of Herbal Medicine Product (HMP) in Regulated and Emerging Market
    A and V Publications ; 2022
    In:  Research Journal of Pharmacy and Technology
    Details
    In: Research Journal of Pharmacy and Technology, A and V Publications
    Abstract: Herbal Medicine Products (HMPs) are ever-present and demand still keeps on the rise, despite of fact that modern medicines are well developed. So, regulative intervention and attempts by various regulatory bodies across the globe to ensure the safety, quality, and efficacy of HMPs have been a real-time challenge. While Allopathic medicines principally depict chemical substances, and those interactions had been well-known, validated also, proper regulatory standard then relevant measures are put into action. HMPs, instead by and large consisting numerous ingredients holding multifaceted combinations along with plant constituents then frequently likewise comprise of roughly anonymous complexes, therefore, building affecting regulatory framework toward measure affecting worth about those drugs is more tricky. So, through this manuscript efforts have been made to summarize definitions, basis of formulating policies and measures pertaining on registration and regulation of herbal medicinal products (HMPs) for both regulated and emerging markets i.e., United States, India, China, Japan, and Europe.
    Type of Medium: Online Resource
    ISSN: 0974-360X , 0974-3618
    URL: Journal
    URL: Article
    DOI: 10.52711/0974-360X
    DOI: 10.52711/0974-360X.2022.00328
    Language: English
    Publisher: A and V Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2846942-2
    SSG: 15,3
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  • 5
    Online Resource
    Online Resource
    Big Pharma's Recent Challenges
    Bentham Science Publishers Ltd. ; 2014
    In:  Applied Clinical Research, Clinical Trials and Regulatory Affairs Vol. 1, No. 1 ( 2014-04-31), p. 28-36
    Details
    In: Applied Clinical Research, Clinical Trials and Regulatory Affairs, Bentham Science Publishers Ltd., Vol. 1, No. 1 ( 2014-04-31), p. 28-36
    Type of Medium: Online Resource
    ISSN: 2213-476X
    URL: Article
    DOI: 10.2174/2213476X114016660001
    Language: English
    Publisher: Bentham Science Publishers Ltd.
    Publication Date: 2014
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  • 6
    Online Resource
    Online Resource
    Anti-Monopoly and Competition Laws - Impact on the Indian Pharmaceutical Industry
    Bentham Science Publishers Ltd. ; 2015
    In:  Applied Clinical Research, Clinical Trials and Regulatory Affairs Vol. 2, No. 3 ( 2015-12), p. 153-157
    Details
    In: Applied Clinical Research, Clinical Trials and Regulatory Affairs, Bentham Science Publishers Ltd., Vol. 2, No. 3 ( 2015-12), p. 153-157
    Abstract: Competition is a process of economic race between market participants to draw clients. The Indian competition law establishment is an early administration. Before the enactment of the Competition Act in May 2002, Monopolistic and Restrictive Trade Practices (MRTP) Act was the active law that managed certain parts of the opposition. Objective: This manuscript highlights the purpose of competition laws for grappling with the monopolies and restrictive trade practices with a particular focus on pharmaceuticals. Conclusion The Competition Act highlights the main features of new competition law which put back the old MRTP act and also lets in the proscription of anti-competitive treaties, prevention of misuse of dominance and combinations which prove detrimental to the competition in the market.
    Type of Medium: Online Resource
    ISSN: 2213-476X
    URL: Article
    DOI: 10.2174/2213476X0203160219101526
    Language: English
    Publisher: Bentham Science Publishers Ltd.
    Publication Date: 2015
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  • 7
    Online Resource
    Online Resource
    Endocrine Disruptors Regulatory Waves: A Frictional Lens Perspective on Regulated and Emerging Markets
    International Journal of Pharmaceutical Sciences and Drug Research ; 2020
    In:  International Journal of Pharmaceutical Sciences and Drug Research Vol. 13, No. 02 ( 2020-03-30), p. 230-239
    Details
    In: International Journal of Pharmaceutical Sciences and Drug Research, International Journal of Pharmaceutical Sciences and Drug Research, Vol. 13, No. 02 ( 2020-03-30), p. 230-239
    Abstract: Endocrine-disrupting chemicals (EDCs) are significantly costing humanity, which upshots the increase in disease and disability. However, unlike other toxicant classes—EDCs have yet to be cataloged onto regulations in a mature way across the globe. This manuscript intends to serve up as a compendium of information that endows with an overview of existing regulatory frameworks and policies those deal with EDCs. In particular, it spotlights on frameworks that explicitly address EDCs (i.e., frameworks that consider both adverse effects and their endocrine causes in the assessment of chemical(s)). Precisely frameworks from 12 countries have been acknowledged, and information crucial to understanding the basic functioning has been summarized (including the scope and general procedures/practices relevant for EDCs, criteria, and data requirements). An attempt has been made to scan not only economical, regulatory policies available for regulated (USA, Europe, Australia, and Japan) and emerging markets (China, Brazil, South Africa, India, Bangladesh, Korea, and Malaysia), but also illustrate perspective for improvement.
    Type of Medium: Online Resource
    ISSN: 0975-248X
    URL: Article
    DOI: 10.25004/IJPSDR.2021.130218
    Language: Unknown
    Publisher: International Journal of Pharmaceutical Sciences and Drug Research
    Publication Date: 2020
    detail.hit.zdb_id: 2548976-8
    SSG: 15,3
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  • 8
    Online Resource
    Online Resource
    Voicing regulatory perspectives of the combination products
    SAGE Publications ; 2020
    In:  Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Vol. 16, No. 3 ( 2020-09), p. 101-111
    Details
    In: Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, SAGE Publications, Vol. 16, No. 3 ( 2020-09), p. 101-111
    Abstract: Combination products (CPs) are nothing but medical products that do not adequately apt solely into a regulatory category, but reasonably comprise of any combination of drug, device and biological product. The use of combination products and delivery systems are to deal with a chronic condition or to relieve an acute condition or to treat the various lives threaten & complex diseases. This article assesses the regulation of combination products in USA, India, China, Japan and Europe and likens the regulatory regime in pharmaceutical environments. Though many of these types of products have been available for years, recent FDA guidelines have spelled out viewpoint on both a development and commercialization perspective. These elucidations have led to augment regulatory expectations resulting in new and increased challenges. To make sure compliance with these regulations and beat challenges, it is essential to remain familiar with the dynamic changing regulations. This piece of writing spotlights on key aspects to understand the concept of combination products, its classification, review period and most importantly facts to consider when any organization is gearing up for a regulatory submission to regulatory agency and its prospective for PLCM of the combination product.
    Type of Medium: Online Resource
    ISSN: 1741-1343 , 1741-7090
    URL: Article
    DOI: 10.1177/1741134320936724
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2174701-5
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  • 9
    Online Resource
    Online Resource
    505(b) (2) - A smart pathway to differentiate from competitive, low margin environment of generics
    SAGE Publications ; 2021
    In:  Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Vol. 17, No. 4 ( 2021-12), p. 183-194
    Details
    In: Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, SAGE Publications, Vol. 17, No. 4 ( 2021-12), p. 183-194
    Abstract: 505(b) (2) application is one of the advantageous ways of regulatory submission. This submission approach can lead to fast-track approval for wide-ranging products, exclusively for those that exemplify a limited change from formerly approved drug. Safety and efficacy evidence in terms of non-clinical and clinical portion of the Reference Listed Drug (RLD), are trusted upon. Additionally, supplementary data essentially required to establish comparability with the RLD, are presented in the dossier. Methods This retrospective analysis is to understand the FDA's expectations and avoid errors in terms of data support approval for a new product submitted under the 505 (b) (2) route. The current script is an analysis on how to architect 505(b) (2) regulatory strategy by developing a different set of documents/information. Results The ultimate goal of this review is to allow drug developers to easily navigate through various 505 (b) (2) submissions and defense strategies for registration processes available to the new drug manufacturers and to understand an effective, safer filing route by facilitating early market launch with a prospect of lower cost. Conclusion Before considering option 505 (b) (2), general companies should have a good understanding of product’s potential productivity, scalability, patent infringement, expensive clinical studies and/or non-clinical studies to appropriately strategize scientific and commercial opportunities. This leverage will potentially quicken the development program and will definitely lower the clinical and regulatory risk of new product entrants.
    Type of Medium: Online Resource
    ISSN: 1741-1343 , 1741-7090
    URL: Article
    DOI: 10.1177/1741134320987866
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2174701-5
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  • 10
    Online Resource
    Online Resource
    Cosmetics: Regulatory Scenario in USA, EU and India
    Chitkara University Publications ; 2015
    In:  Journal of Pharmaceutical Technology, Research and Management Vol. 3, No. 2 ( 2015-11-17), p. 127-139
    Details
    In: Journal of Pharmaceutical Technology, Research and Management, Chitkara University Publications, Vol. 3, No. 2 ( 2015-11-17), p. 127-139
    Abstract: The efficacy, safety, regulatory framework, and marketing of cosmetic products are the most important factors for the growth of the cosmetic industry. The safety of cosmetic goods is regulated by diverse regulatory bodies around the globe who all have their own rules and regulations. The regulations of cosmetics like, nomenclature, labeling, and safety of colorants(s) alter in different countries. Much stringent legislation exists in the European Union (EU) and The United States of America (USA) has very much stringent legislation in order to regulate the use of cosmetic products. The safety assessments of cosmetic products are affected by the different regulations of different regulatory bodies. Nevertheless, there is a need for harmonized regulations throughout the world. An attempt has been made in the present manuscript to compare the current regulatory scenario of cosmetics in the USA, EU, and India.
    Type of Medium: Online Resource
    ISSN: 2321-2217 , 2321-2225
    Uniform Title: Cosmetics: Regulatory Scenario in USA, EU and India
    URL: Issue
    URL: Journal
    URL: Article
    DOI: 10.15415/jptrm.2015.32
    DOI: 10.15415/jptrm
    DOI: 10.15415/jptrm.2015.32010
    Language: Unknown
    Publisher: Chitkara University Publications
    Publication Date: 2015
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