GLORIA

GEOMAR Library Ocean Research Information Access

Your email was sent successfully. Check your inbox.

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

Proceed reservation?

Export
  • 1
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 3 ( 2019-09-15), p. 48-62
    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
    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 ...
  • 2
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 2 ( 2019-06-16), p. 51-61
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 2 ( 2019-06-16), p. 51-61
    Abstract: To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. This agreed upon common format in the form of CTD format and ACTD format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will be more ease to submit the file having electronic database.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
  • 3
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 3 ( 2019-09-15), p. 40-47
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 3 ( 2019-09-15), p. 40-47
    Abstract: Sucralfate is a biologically inert non-systemically acting compound. It requires polymerization for conversion into its biological active form, polymerized Sucralfate. Should this conversion occur in the body, using processes of the body to effect conversion subsequent to administering a dose, then the administered Sucralfate is a drug, as it enlists bodily functions to enact a chemical change. This form of Sucralfate should be regulated as drug. On the other hand, Sucralfate is manufactured as a polymerized product, requiring no bodily functions to enable its therapeutic effect, then this form of Sucralfate act as a medical device and should be regulated as such. This dichotomy of Sucralfate was first recognized by the US FDA in 2005 that subsequently cleared several polymerized Sucralfate barrier therapies as medical devices.This review covers the history of the regulatory dichotomy or duality of Sucralfate, the biological basis for Sucralfate clinical effects and the regulatory position of several barrier therapies.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
  • 4
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 2 ( 2019-06-16), p. 17-34
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 2 ( 2019-06-16), p. 17-34
    Abstract: The biopharmaceutical industry has gained significant interest in the last decade as the numbers of blockbuster biologic products are losing their patent rights. The regulatory authority is also providing marketing approval for Biosimilar products. Biological medicines are biotechnology developed drugs having large molecule which is complex in nature and are very sensitive to manufacturing conditions and parameters. Even a minor change in manufacturing conditions alters the quality and safety aspects of end product owing to increased risk for immune response. Biopharmaceutical companies use information technology such as molecular modelling and statistical data for drug development. Biosimilar drugs have moderate marketing cost which is alluring and generally 40 to 50 % less to that of originator drug product. Biosimilars are also known as “follow on biologics” or “similar biologics”. The following points needs consideration such as global harmonization, extrapolation studies, interchangeability study, long term post marketing studies to gain physician confidence in biosimilars.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
  • 5
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 3 ( 2019-09-15), p. 34-39
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 3 ( 2019-09-15), p. 34-39
    Abstract: A Biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorized (the „biological reference medicine‟). The expiration of the patents on many biological products has prompted the development of these products as similar biological products. The European Medicinal Agency (EMEA) has done a commendable job at creating the regulatory path to facilitate approval of biosimilars. The Health Product Act requires all medicinal products sold in Singapore and manufactured locally for export to be licensed with the Health Products Regulation Group, Health Science Authority (HAS). Biosimilar products are eligible for the New Drug Application (NDA-2 and NDA-3) application types. The Biosimilar product should be evaluated and approved by at least one of HAS‟s reference agencies namely Australia, Health Canada, Europe, United States. Approved biosimilars must be demonstrated, through extensive characterization and appropriate clinical trials, to be as safe and effective as originators for the benefit of patients.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
  • 6
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 2 ( 2019-06-16), p. 1-6
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 2 ( 2019-06-16), p. 1-6
    Abstract: The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person. The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will: Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1). Explains the Australian regulatory requirements for supplying of Biologicals Explains what is required for the market authorization as per TGA especially for Biologicals.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
  • 7
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 4 ( 2019-12-18), p. 28-35
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 4 ( 2019-12-18), p. 28-35
    Abstract: Introduction: Service quality is a unique and abstract concept that is difficult to define and measure. It is an overall customer judgment that results from the comparison between service expectations and perceptions. There is no information on customers’ perception of pharmaceutical regulatory service quality in Ethiopia. Hence, this study aimed to assess customers’ perception of the Ethiopian Food, Medicine and Healthcare Administration and Control Authority’s pharmaceutical regulatory service quality. Materials and methods: Cross-sectional study design was conducted from March 30 to May 30, 2017. Using simple random sampling technique, 131 respondents were included in the study. Structured questionnaire adapted from the SERVQUAL model was used to collect the data. Paired sample t-test and descriptive statistics were used for data analysis. Results: The study found out that pharmaceutical regulatory service quality was low. Negative service quality gaps were observed in the five service quality dimensions and overall service quality. The widest service quality gap was in reliability and the narrowest gap was in the tangibility and assurance dimensions. The perception and expectation mean scores were 1.897±0.61 and 3.433±0.559 respectively. Conclusions: Only 21.4% of the customers perceived that there was good service quality in the Authority while 78.6% claimed as poor. The study showed that there are service quality gaps in the pharmaceutical regulatory services. Hence, managers should look into the unmet needs and expectations or low perceptions of customers; and formulate effective strategies to ensure provision of better service quality.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
  • 8
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 3 ( 2019-09-15), p. 30-33
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 3 ( 2019-09-15), p. 30-33
    Abstract: The India Draft National eCommerce Policy is a high-level policy document proposed by India's Department for Promotion of Industry and Internal Trade in February 2019. It sketches out a series of policy recommendations that range from useful consumer protections to non-constructive protectionist industry regimes that would likely backfire and hurt businesses, entrepreneurs and consumers alike. The best of these recommendations would institute stricter consumer protections against annoying, unsolicited phone calls and emails. But the worst of them would make data transfers difficult, impose onerous liability on third party platforms, and institute data localization that would reduce business and consumer choices.Within India, the draft policy boosts the government‟s schemes/ programmes, such as Digital India, Skill India, Make in India and Startup India, which rely on eCommerce and its components. For instance, it has introduced norms for consumer protection, recognized the importance of data, its protection and storage, granted infrastructure status to data centers and server farms, integrated different systems to track imports and introduced anti-counterfeiting and anti-piracy measures.It is also in sync with the recently updated industrial policy which reflects the underlying brick-and-mortar economy. However, the stakeholders, including industry, its associations and the independent policy community, point out that in the government‟s enthusiasm to address all these many aspects of eCommerce, the Draft Policy has become ambiguous, raising questions about whether it is intended to be an internet policy or a specific eCommerce policy. (1)The National eCommerce Policy is aimed to address concerns which go beyond the sale and purchase of products by electronic means. For example, environmentally sustainable growth by outlining regulatory aspects on Swachh Bharat Abhiyan, suitable policy will be devised to promote “reduce, reuse and recycle” practices by stakeholders. In the era of Industrial Revolution 4.0, economic development is based on data which is generated, stored, transmitted or processed in large volumes. The increasing importance of data warrants treating it at par with other resources on which a country would have sovereign right. The Policy recognizes the importance of data while enabling the domestic industry to benefit from the advantages and opportunities created by electronic commerce. (2)
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
  • 9
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 2 ( 2019-06-16), p. 42-50
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 2 ( 2019-06-16), p. 42-50
    Abstract: A Pre-filled syringe is a disposable syringe that is supplied already loaded with the substance to be injected. It is a unit dose of parenteral medication to which a needle has been fixed by a producer. They are small which make them easy to carry and are dependable for delivering a precise dose of medication. These reasons are leading to growth of parenteral medication in pharmaceutical market. The intent of this review article is to provide information on regulatory guidelines involved in submission approach for marketing authorization of pre-filled syringe in developed region (USA, EU) and developing region (India). It also further explains about complexities associated with Pre-filled syringes in terms of regulations, submission approaches and quality development considerations in developing region. There is a need to develop an effective regulatory framework to make regulations of Pre-filled syringes more comprehensive for regulatory bodies. A harmonized forum to be made through which single application can be made and single review process can be followed to avoid deviations in regulatory pathways.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
  • 10
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2019
    In:  International Journal of Drug Regulatory Affairs Vol. 7, No. 4 ( 2019-12-18), p. 8-13
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 7, No. 4 ( 2019-12-18), p. 8-13
    Abstract: The success of the promotion policies of the Medicines Derived from Traditional Pharmacopoeia (MDTPs) requires a regulation that is adapted to realities and guarantees their quality, efficiency and safeness. This study aims to analyze the legal texts and the current guiding principles obtained from the heads of the departments in charge of traditional medicine in Burkina Faso and Benin. The documents collected from the two countries have been analyzed comparatively and also in relation to WAEMU regulations and the WHO recommendations. Several texts, dealing with the activity, products, facilities and advertisement related to traditional medicine, have been recorded in both countries. The regulation battery of Burkina Faso is more extensive than that of Benin, especially on traditional medicine and pharmacopoeia facilities. In addition, unlike biomedicines, the West African Economic and Monetary Union (WAEMU) and the West African Health Organization (WAHO) have not yet passed community laws on MDTPs. To limit disparities in legal frameworks between the countries of the same sub-region, it is important that the WAEMU or WAHO be involved in the harmonization of pharmaceutical regulations by setting Community rules in the domain.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    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 ...
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...