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  • Society of Pharmaceutical Tecnocrats  (7)
  • 2010-2014  (7)
  • 1
    Online Resource
    Online Resource
    OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 1 ( 2013-02-05), p. 1-4
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 1 ( 2013-02-05), p. 1-4
    Abstract: Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceuticalindustries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized variousindustries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a veryspecific meaning within the pharmaceutical industries.DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionalsare dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.RA as profession is broader than registration of products, they advise companies both strategically and technically at thehighest level. Their role begins right from development of a product to making, marketing and post marketing.Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientificthinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are alsoplaced upon the claims which can be made for the product on labeling or in advertising.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i1.1
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2013
    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
    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
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    Online Resource
  • 3
    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
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    Online Resource
  • 4
    Online Resource
    Online Resource
    RISK DRIVERS OF FALSIFIED AND SUB-STANDARD MEDICINES IN EAST AFRICA: PERCEPTIONS AND PRACTICES OF PHARMACEUTICAL DRUG FACILITY OWNERS/EMPLOYEES
    Society of Pharmaceutical Tecnocrats ; 2014
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 3 ( 2014-09-06), p. 1-8
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 3 ( 2014-09-06), p. 1-8
    Abstract: An interview survey was conducted among drug shop owners to investigate the access to and perception ofcounterfeit medication along transport corridors of East Africa spanning Kenya, Tanzania, Uganda and DemocraticRepublic of Congo. Owners of 171 retail drug outlets of modern medicines were interviewed on their knowledge,perception, and practices related to counterfeit medicines. Forty-four (44) encounters with counterfeit medicines werereported. Twenty-two (22) of the 171 interviewed drug store owners said that quality was the least important aspectthey considered when procuring drugs. Generally, 65.9% of the drugs were sourced from registered wholesalers anddistributors while the remaining 34.1% were supplied by unregistered in-country or cross-border sales representatives.In all the four countries, the 10 fastest moving drugs were reported to originate from 27 different countries with most(39%) from India. From 171 interviewees, 135 acknowledged that they were aware of the existence of counterfeitdrugs, 106 of whom attributed their level of awareness to mass media. Only 32 of the interviewees reported havingreceived any formal training on counterfeit medicines at seminars or workshops. 160 of the intervieweesacknowledged that counterfeit drugs pose a major threat to the patient and pharmaceutical market. The region has aplethora of drug outlets run by attendants with varying backgrounds, diverse knowledge on medicines and practicepatterns. There is an urgent need for medicine regulators and other stakeholders in Africa involved in medicine safety,to focus on properly regulating these outlets and also standardizing and training the drug outlet personnel. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i3.9
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2014
    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
    MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 3 ( 2013-10-31), p. 1-6
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 3 ( 2013-10-31), p. 1-6
    Abstract: Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i3.5
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2013
    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
    A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA
    Society of Pharmaceutical Tecnocrats ; 2014
    In:  International Journal of Drug Regulatory Affairs Vol. 2, No. 1 ( 2014-03-06), p. 1-11
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 1 ( 2014-03-06), p. 1-11
    Abstract: Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India. 
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v2i1.7
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2014
    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
    LIPOSOME AS A DRUG DELIVERY CARRIER-A REVIEW
    Society of Pharmaceutical Tecnocrats ; 2013
    In:  International Journal of Drug Regulatory Affairs Vol. 1, No. 1 ( 2013-02-05), p. 16-19
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 1, No. 1 ( 2013-02-05), p. 16-19
    Abstract: The evolution of the science and technology of liposomes as a drug carrier has passed through a number ofdistinct phases. Because they exhibit peculiar properties due to their structure, chemical compositionamphiphilic nature, physico-chemical characters and colloidal size, which are used in various applications.These properties point to several applications as the solubilizer for insoluble drugs, dispersants, and sustainedrelease system, delivery system for the encapsulated substance, stabilizer, protective agents, and micro reactivebeing the most obvious ones. Yet interest in liposomes, especially among academic workers, spread rapidly weattribute this to the remarkable structural versatility of the system, which enables the design of countlessliposomes versions to satisfy particular needs in terms of both technology and optimal function in vivo.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v1i1.2
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2013
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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    Online Resource
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