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  • Society of Pharmaceutical Tecnocrats  (103)
  • 2020-2024  (103)
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  • Society of Pharmaceutical Tecnocrats  (103)
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  • 2020-2024  (103)
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  • 1
    Online Resource
    Online Resource
    Regulatory perspective of Drug Repurposing: Methods, Regulatory pathways and Hurdles
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-19), p. 39-45
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 2 ( 2022-06-19), p. 39-45
    Abstract: Drug repurposing is a phenomenon that aims at utilising an established and approved drug product or drug substance for an additional clinical indication apart from the one that it was intended for. The reprofiling of drug formulations creates an extensive arsenal of therapeutic options for drug products, thus making the practice a desirable and forthcoming procedure. There are several techniques and methods that have been adopted over the years to evaluate the various possibilities for the repurposing of drugs in search of a wider range of chemical therapeutics. The repurposing of drug products has provided, over the course of time several different advantages to the pharmaceutical industry, and yet remains an uncomprehended and over-looked procedure. The following paper attempts to identify the different benefits that are to be gained from the repurposing of drug products along with the approaches that have been used for the same. Additionally, the paper also discusses the regulatory perspective of drug repurposing, emphasising on the incentives that are available for various pharmaceutical sponsors as well the hurdles that are to be faced during the repurposing of a drug product or drug substance.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i2.520
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    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
    FDA's drug regulatory pathways, its development strategies and regulatory considerations
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 2 ( 2021-06-15), p. 6-15
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 2 ( 2021-06-15), p. 6-15
    Abstract: People who are interested in drug development may be aware that New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) are 2 of the FDA's regulatory pathways for how prescription drugs can be approved and ultimately reach the market. In basic terms, NDAs are for new drugs that have not yet been approved and ANDAs are for generic products. NDA, also called 505 (b)(1), is the format that manufacturers use to bring a formal proposal to the FDA that a new drug should be approved and made available for use by patients in the United States. Under 505(b)(1), all investigations supporting safety and effectiveness, both clinical and nonclinical, are conducted by or on behalf of the sponsor. The other pathway is termed as abbreviated because preclinical and clinical trials are not required. The abbreviated approval pathways are described in section 505(j) and 505(b)(2) of the FD & C Act and known as ANDA and Hybrid applications respectively. Hatch-Waxman amendments in 1984 provided for a suitability petition that allows the application of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient). The differences allowed for suitability petition and 505(b)(2) application are same but ANDA filed through suitability petition can contain only those differences that do not need clinical evidence for efficacy and safety. This article identifies considerations to help potential applicants determine the appropriate submission pathway, its development strategies to support approval under those pathways.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v9i2.460
    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
  • 3
    Online Resource
    Online Resource
    A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 4 ( 2021-12-26), p. 20-32
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 4 ( 2021-12-26), p. 20-32
    Abstract: A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical field as, it is related to healthcare products. It provides strategic, operational direction and support for working within regulations to expedite the development of pharmaceutical, biological and medical devices. Also, it is principally concern with safety and efficacy, low risk/high benefit and quality assessment of healthcare drug products throughout the world. Regulatory system of each and every country has different regulatory agencies which govern certification and good manufacturing practices. Regulatory Affairs also has a very specific importance within the formulation and marketing of drug product in pharmaceutical industries. Current abstract reports for the first time and emphasizes on studies concerning awareness and knowledge testing in regulatory affair field by the various pharma professionals. This is completely certified online survey of quiz questionnaire based on important concepts in RA and circulated via google form to different social medias to more than 1000 pharma professionals (Academics, Students, Industrials area). The systematic analysis of received responses reveals awareness and knowledge of the participants about RA in selected pharma professionals. It shows that, participants form industrial area having more knowledge than academics and students. This survey comes out with conclusion that, there is more need to raise RA information sources by the inclusion of this subject in syllabus for academics via various courses to fulfill more RA professional demands in future.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v9i4.495
    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
  • 4
    Online Resource
    Online Resource
    Regulatory procedures for emergency approval of medical products by regulatory agencies
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 2 ( 2021-06-15), p. 1-5
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 2 ( 2021-06-15), p. 1-5
    Abstract: Emergency use authorization of medical products by the regulatory agencies is not a usual procedure; it happens to cope with unanticipated health emergencies affecting a large group of population, these can be because of outbreak agents like virus, bacteria, etc., which can cause contagious diseases. Contagious diseases are classified into an outbreak, epidemic and pandemic disease, based on size and intensity of spread of the disease. Epidemic and Pandemic disease conditions such as CoVID-19 will trigger the emergency use authorization of products that help in the control, prevention and/or cure for the disease. EMA and FDA are well known advanced regulatory bodies, with eminent procedures for approval of the medication, harmonization of the standards as per the global regulatory acceptance. However, there are some differences between the two, in case of initiating the procedure, timelines, data required for approval of products under the emergency use. This article focuses on emergency approval of medications, regulations involved in the approval of medications and vaccines by EMA and FDA, some of the important data companies or sponsors need to submit to the regulatory bodies for approval, verification procedure and timelines for evaluation of manufacturer submitted data. Mutual recognition agreement and timeline of Remdesivir for approval by EC and FDA.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v9i2.459
    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
  • 5
    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
    Location Call Number Limitation Availability
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    Online Resource
  • 6
    Online Resource
    Online Resource
    Comparative study of Regulatory requirement for preparation of Dossier for Registration of Veterinary Drug in US, EU and Canada
    Society of Pharmaceutical Tecnocrats ; 2023
    In:  International Journal of Drug Regulatory Affairs Vol. 11, No. 3 ( 2023-09-17), p. 62-67
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 3 ( 2023-09-17), p. 62-67
    Abstract: The main purpose of this article is to research the requirement of the veterinary drug dossier submission in the three countries is US, EU, and Canada and the procedure of all the three countries are different for the submission of the veterinary drug dossier and their rules and regulation are different but all the three countries follow the VICH guidelines in these articles all the information available like necessary documents timeline approval procedure are different for US, EU, and Canada.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v11i3.619
    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
  • 7
    Online Resource
    Online Resource
    Assessment of Regulatory requirements and filing procedure of Drug Master File for Brazil, Europe and South Africa
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-19), p. 14-27
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 2 ( 2022-06-19), p. 14-27
    Abstract: A Drug Master File is a record that consists of detailed, correct data approximately an Active Pharmaceutical Ingredient (API) or Dosage Form of a Finished Product (FP). It is a classified document containing thorough, accurate, and up-to-date information regarding the active medicinal ingredient and medicament. A DMF is divided into two sections: (a) Open part (the Applicant's Part), which includes all of the details needed to determine the quality of a product. And (b) the Closed Part (Restricted Part). The Restricted Part (Closed Part) comprises openly undisclosed manufacturing method knowledge only given to authorized individuals. This compilation aims to offer a comparison of DMF regulatory necessities in addition to the exact data for the registration of lively pharmaceutical ingredients (API) for common drugs in various regulatory governments, including EUROPE (EDQM, EMA), BRAZIL (ANVISA), and SOUTH AFRICA (SAHPRA). This review will provide information on the differences and similarities in the DMF filing requirements in EUROPE, BRAZIL, and SOUTH AFRICA. The regulatory criteria for API registration vary by jurisdiction. Despite the existence and widespread adoption of an ICH-CTD standard format, there are also some limitations. There are a few particular requirements set provided to drug authorities along with the submission. The registration procedure is a regulatory undertaking that permits a person/organization/sponsor/innovator to get permission to participate in the regulation process for fetching marketing authorization/approval.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i2.517
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 8
    Online Resource
    Online Resource
    Oncology Drugs: Evolution, Comparative study of Global Drug Regulatory approval process and various measures to improve availability and accessibility
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-28), p. 102-111
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 2 ( 2022-06-28), p. 102-111
    Abstract: Cancer is the leading cause of death worldwide and is a well-known fact that it can be cured if detected and treated early. Cancer treatment has evolved from conventional therapies like vinca alkaloids, photodynamic and radiation therapy, chemotherapy to immunotherapy. Recent advances in tumour agnostic therapies based on cancer genetics and molecular features has led to a single drug treating different types of cancers. Next Generation sequencing (NGS) represents an effective way to gather large amount of genomic information about a cancer. The concept of precision medicine goes along with an understanding of the cancer genome as determined by NGS. Thus with an array of cancer diagnosis and treatment options the marketing approval process globally is challenging. This is mainly due to lack of harmonization of guidelines. This review evaluates the approval process of oncology drugs in US, EU and India.  Recent USFDA initiatives like Project Orbis involving multi country collaboration and real time oncology review while EU PRIME and WHO proposed reliance pathway are several global initiatives which accelerates assessment process. New NDCT rules introduced in India in 2019 is one of the key step towards faster availability and accessibility of Cancer drugs in the country. Countries with high resource settings like USA and EU have recognized this and have made several initiatives to provide early access to patients. USA has several pathways for speeding up the regulatory approval process for oncology drugs. India has recently came up with New Drugs and Clinical Trial rules, 2019 (NDCT rules 2019) which laid down the provisions of Provisions of Accelerated approval, Expedited review and Clinical trial waivers ensures faster availability and accessibility  of  cancer drugs in the country. Although a lot of initiatives have already been taken in this direction still there is a strong need to harmonize the requirements globally for faster availability and accessibility of drug in the country for the much-needed patients.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i2.542
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 9
    Online Resource
    Online Resource
    Regulatory requirement for the approval of Generic Drug in Vietnam as per ASEAN Common Technical Dossier (ACTD)
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 3 ( 2022-09-19), p. 66-69
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 3 ( 2022-09-19), p. 66-69
    Abstract: Drug approval process differs from one country to another country. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Vietnam. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i3.532
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
  • 10
    Online Resource
    Online Resource
    Preventing Prescription Drug Misuse: A Regulatory Perspective in the United States, Europe, and India
    Society of Pharmaceutical Tecnocrats ; 2021
    In:  International Journal of Drug Regulatory Affairs Vol. 9, No. 4 ( 2021-12-28), p. 46-52
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 4 ( 2021-12-28), p. 46-52
    Abstract: Prescription medicines, such as analgesics, stimulants, steroids, anti-depressants, psychotropics, and certain antibiotics are commonly mishandled in a variety of ways, including overdosing, abuse, diversion, and drug trafficking. Because of the considerable risk to public health, they are subject to strict regulatory oversight. The drugs possess abuse potential at specific dose and hence prone to abuse therefore they are categorized as Controlled substances. Therefore, they are subject to constant vigilance over the pharmaceutical supply chain. The complete clinical data as well as post marketing surveillance study of such drugs are critical to be in place as per the regulatory requirements. The countries have kept up with the times by constantly updating the system with regulatory laws and strategies to prevent cases of misuse. The current review will give a quick summary of how prescription medications and prohibited substances are regulated in the United States, Europe, and India. It will also emphasize current trends in drug usage, as well as the issues that these countries face and the preventive policies implemented to manage and prevent drug misuse. It will also make recommendations for new regulatory initiatives to address the current drug- misuse-related concerns. As a result, a review of the regulatory system in various countries will present current challenges and new lessons for countries around the globe.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v9i4.502
    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
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