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  • 1
    Online Resource
    Online Resource
    REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2018-02-13), p. 62-74
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2018-02-13), p. 62-74
    Abstract: The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug registration requirements and processes differ among the countries. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. In ASEAN region, documentation can be filed in the ACTD format. Even though ACTD format is mandatory from 2009, the member countries have their own requirements for registration process like administrative documents, labeling. The purpose of this paper is to give a comparative overview on the Drug regulatory requirement for generics in two of the ASEAN countries which are Singapore and Thailand.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i1.158
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    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
    REGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2018-02-12), p. 7-15
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2018-02-12), p. 7-15
    Abstract: Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Ghana is considered as one of the growing pharmaceutical market in east Africa. Of late, generic drugs are holding a major stake in the pharmaceutical market and are gaining more and more confidence in the usage. Majority of medicines in the Ghana are generic drugs which are considered as value for the money and affordable. With Ghana Regulatory Authority is the Food and Drugs Board, which takes decision to register the product and issues Registration Certificate. This study mainly focuses on the regulatory environment, registration process involved and the regulatory requirements that are applicable for the generic drug products in Ghana.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.126
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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    Online Resource
  • 3
    Online Resource
    Online Resource
    THE PATH OF PERSONALIZED MEDICINE: REGULATORY PERSPECTIVE
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2018-02-13), p. 14-29
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2018-02-13), p. 14-29
    Abstract: Personalized medicine (PM) has become a topic of great interest because of its potential to improve patient care and optimize therapeutic strategy. The way we understand and treat disease is changing rapidly. The traditional form of personalized medicine has been based on the observable manifestations of a disease or treatment, such as a tumour on a mammogram, the appearance of cells under the microscope, etc. But now personalized medicine promises to introduce a new standard of healthcare by using molecular analysis to achieve optimum medical outcomes in the management of a patient’s disease or disease predisposition. PM is providing the right treatment, to the right patient at the right time by using modern biology’s new methods and tools. The objective of this paper is to focus on a realistic scenario for its evolution, and to explore the issues affecting the development and implementation of personalized medicines and various regulatory pathways involved in its regulation. This paper also highlights the roles and applications of personalized medicine. The success of personalized medicine depends on having accurate diagnostic tests that identify patients who can benefit from targeted therapies. The common goal: an integrated policy framework that balances patient, industry and scientific interests without hindering advancement of this tremendously important sector. Through these efforts, we can help ensure that personalized medicine is able to fulfil its promise as rapidly as possible.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i1.155
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    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
    GLOBAL REGULATORY APPROACH TOWARDS M-HEALTH
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 4, No. 1 ( 2018-02-13), p. 6-12
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 4, No. 1 ( 2018-02-13), p. 6-12
    Abstract: The past decade has witnessed rapid advancement in telecommunication and computer technologies. The smart phone is one result of that technological development and has been adopted by hundreds of millions of people worldwide. Innovators in the medical device industry quickly recognized the potential to use smartphones to expand the capabilities of healthcare professionals via mobile medical applications (apps) resident on these devices. These apps raise unique challenges for regulation by the drug regulatory authorities worldwide including the Food and Drug Administration (FDA), European Medical Association (EMA) etc. The focus of this article is to shed light on the current trends and future aspects of the regulatory framework implied on the Mobile Health (mHealth).
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v4i1.176
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    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
    SOFTWARE AS MEDICAL DEVICE
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 4, No. 2 ( 2018-02-13), p. 10-18
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 4, No. 2 ( 2018-02-13), p. 10-18
    Abstract: The use of software in a medical device allows the manufacturer to concentrate on the application needed to run device-specific functions. The medical device manufacturer using software generally neglect software life cycle control, but still bears the responsibility for the continued safe and effective performance of the medical device. Software created for medical purposes and non-medical purpose is being used in healthcare. Earlier, hardware was more important; but in the recent times software one of the element for overall implementation has surpassed the prominence than hardware. Software is vital for the design, architecture and functionally of medical devices. Regulatory bodies have taken approaches in developing definitions and frameworks for software that have common public health goals, with variations in approach. Regulatory guidelines from such regulatory bodies for medical software established and implemented, serves as an environmental scan to provide direction on the guidelines on proposed regulatory framework for adoption, based on best practices. Medical software regulation is aimed to facilitate member economies to establish and harmonize an economic and effective approach for control of medical software in the interest of public health, in the continued innovation of medical software development.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v4i2.181
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    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
    EMERGENCY USE AUTHORIZATION: AT ZERO HOUR
    Society of Pharmaceutical Tecnocrats ; 2018
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 4 ( 2018-02-13), p. 18-23
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 4 ( 2018-02-13), p. 18-23
    Abstract: The Emergency Use Authorisation (EUA) authority plays a vital role in US FDA. They provide the authority/permission to use the unregistered products/registered product with unregistered route to treat the life threatening damages to the patients in world in some emergency conditions. The aim of this work is to give an overview on EUA in life threatening conditions and there challenges in getting the permissions under regulations with example of E-bola virus. The e-bola is a virus. It is a hemorrhagic fever deadly disease caused by one of the E-bola viral strain, which is wide spread in West Africa. The -Secretary of the Department of homeland security (DHS), determined, pursuant to section 319F-2 of the Public Health Service Act, that the Ebola virus presents a material threat against the United States population sufficient to affect national security. Issuance of EUA by the FDA Commissioner requires several steps under section 564 of the FD & C Act. The FDA Commissioner, can only issue the EUA, if criteria for issuance under the statute are met. This study’s highlights the importance of the EUA in emergency when there is no medicine for disease/virus in the world. For example the FDA has issued a EUA to use the ReEBOV which is the Rapid Antigen Test device designed by Lusys lab co. Pvt. Ltd. for detecting the Zaire Ebola virus.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i4.173
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2018
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
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