GLORIA

GEOMAR Library Ocean Research Information Access

X

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 11
    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
    BibTip Others were also interested in ...
    Online Resource
  • 12
    Online Resource
    Online Resource
    ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012)
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2018-02-13), p. 41-61
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2018-02-13), p. 41-61
    Abstract: A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. The United States - Food and Drug Administration (U.S. FDA) has its own regulatory strategy to approve and allow generic drugs in to the market, which is named as Generic Drug Submission Review. FDA would like to slash the review time of generic drug application without compromising the quality and efficacy of proposed generic drugs for the intended use and to make them available to consumers in short time as possible. FDA has introduced Generic Drug User Fee program to supplement appropriate funding for resource management to ensure that consumers continue to receive the significant benefits offered by generic drugs. The purpose of this article is to present a concise overview about Generic Drug User Fee program and the recent advances in Abbreviated New Drug Application (ANDA) review process.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i1.157
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 13
    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
    BibTip Others were also interested in ...
    Online Resource
  • 14
    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
    BibTip Others were also interested in ...
    Online Resource
  • 15
    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
    BibTip Others were also interested in ...
    Online Resource
  • 16
    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
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 17
    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
    BibTip Others were also interested in ...
    Online Resource
  • 18
    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
    BibTip Others were also interested in ...
    Online Resource
  • 19
    Online Resource
    Online Resource
    AN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 3 ( 2018-02-12), p. 14-18
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 3 ( 2018-02-12), p. 14-18
    Abstract: The Drug regulatory authority of China was renewed from state pharmaceutical administration of China (SPAC) to state food and Drug administration (SFDA) with the announcement and declaration of Chinese ministry of health, the established regulatory standards of SFDA were keen to keep with international standards of EU, Japan and USA, the Drug registrations and Drug approvals are carried with established affiliated units for fast track evaluation within prescribed period ordered by SFDA, the state food and Drug administration is developed stringently and modified its standards according to the US healthcare regulatory system, in this review the permanently keeping standards of regulatory functions were detailed, and the untiring responsibilities of affiliated units of SFDA were to be recognized where their performance was a key aspect.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i3.137
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 20
    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
    BibTip Others were also interested in ...
    Online Resource
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...