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
Filter
  • Kumar, Pramod T.M.  (5)
  • 1
    Online Resource
    Online Resource
    DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE
    Society of Pharmaceutical Tecnocrats ; 2015
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 2 ( 2015-06-06), p. 1-7
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 2 ( 2015-06-06), p. 1-7
    Abstract: In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i2.12
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2015
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 2
    Online Resource
    Online Resource
    ACTD: BRIDGE BETWEEN REGULATORY REQUIREMENTS OF DEVELOPED AND DEVELOPING COUNTRIES
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 4 ( 2013-12-06), p. 1-11
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 4 ( 2013-12-06), p. 1-11
    Abstract: Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review andultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provide asafe, effective and low cost which benefits the society. Filing requirements in developed countries differ fromdeveloping countries which makes the approval process tedious and time consuming for the later. To make thisprocess smooth, ASEAN CTD (ACTD) was developed by Association of South East Asian Nations (ASEAN)nations. As format of ACTD resembles the format of Common Technical Document (CTD) with some differences,hence it can be used as a step. Also if both guidelines can be harmonized then differences and variation between boththe guidelines can be minimized. This article focuses on the similarities and differences in between CTD & ACTDand highlights how ACTD can be a initiating step for developing countries to meet pharmaceutical regulations ofdeveloped countries.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i4.6
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2013
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    WEARABLE HEALTHCARE TECHNOLOGY – THE REGULATORY PERSPECTIVE
    Society of Pharmaceutical Tecnocrats ; 2016
    In:  International Journal of Drug Regulatory Affairs Vol. 4, No. 1 ( 2016-02-06), p. 1-5
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 4, No. 1 ( 2016-02-06), p. 1-5
    Abstract: The world today isn’t the one which it was yesterday. With the continuing evolution in technology and technologicalapplications on medical field, innovative products and services have been emerging every day. Wearable gadgetshave risen up as revolution in the medical field for patient care. A number of tech giants are pouring into thissegment; wearables have already shown an impact on various fields such as communication and navigation; butperhaps the greatest potential lies in healthcare. With this article, an attempt has been made to unlock the potential ofwearable healthcare technology and the regulatory aspects imparted on them currently. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v4i1.13
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2016
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 4
    Online Resource
    Online Resource
    A PARADIGM SHIFT IN DRUG REGULATIONS IN TAIWAN
    Society of Pharmaceutical Tecnocrats ; 2014
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 2 ( 2014-06-06), p. 1-4
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 2 ( 2014-06-06), p. 1-4
    Abstract: Across Asia, a convergence of economic trends, government policies and greater awareness among the general public of healthcare issues has created an environment that is poised for dramatic growth and change. Taiwan, for instance, can be taken as an example. Taiwan has one of Asia's most highly-praised healthcare systems with excellent provision of healthcare and key health outcomes. Nevertheless, the government is facing new pressures for public healthcare reforms as result of a rapidly ageing population and rising healthcare costs. This paper provides an introductory overview of Taiwan’s sudden changes in its Drug regulations due to TFDA (The Taiwan Food and Drug Administration) establishment in 2010, TFDA of the Department of Health (DOH) made an advance announcement about the “amendment draft of the Provisions Governing the Registration and Market Approval of Drugs”, which amends a total of 40 Articles. Without impeding the quality, safety and therapeutic effect of Drugs, most of the amended Articles are about simplification of application procedures and loosening of regulations for Drug registration and market approval. Regulations loosened are imposed on new Drugs, Radioactive Drugs, Allergenic Drugs and Drugs for export that is intended to accelerate the process to sell new Drugs on the market and promote the export of domestically manufactured Drugs. As a result of these changes in regulations many pharmaceutical MNCs and local manufacturers explored their business in Taiwan due to quick approval of their NDAs and gained more flexibility in the local market. To support Taiwan's generic Drug industry, DOH has also decided to take measures to simplify and reduce the ANDA application time.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i2.8
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2014
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 5
    Online Resource
    Online Resource
    CLINICAL TRIAL IN INDIA: RISE AND FALL
    Society of Pharmaceutical Tecnocrats ; 2015
    In:  International Journal of Drug Regulatory Affairs Vol. 3, No. 1 ( 2015-03-06), p. 1-13
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 3, No. 1 ( 2015-03-06), p. 1-13
    Abstract: Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices throughclinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, test potentialtreatments in human volunteers to see whether they should be approved for wider use in the general population. Atreatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. India stoodas a global hub for clinical trials in past years. Later, the amendments made in Indian regulations paved for the declineof clinical trials. The aim of this article is to provide the details about the Indian clinical trial application filingprocess, the amendments made in its regulations and the challenges faced by Indian clinical trial industry. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v3i1.11
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2015
    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...