3.Analysis and discussion on current condition of acupuncture clinical research registration.
Chinese Acupuncture & Moxibustion 2015;35(6):605-607
To introduce the international registration condition of acupuncture clinical research. With the examples of World Health Organization International Clinical Trials Registry Platform and the U. S. National Institutes of Health Clinical Registration Platform, the registration method and current condition of acupuncture clinical trials in international clinical trials registration platform were analyzed. The results indicate that the number of acupuncture clinical trials registration is gradually increased and the registration number from China is on the rise as well. But most domestic acupuncture clinical researches haven't been registered arid the researchers' valuing degree for clinical trials registration and methodology research needs to be improved.
Acupuncture Therapy
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standards
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Biomedical Research
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legislation & jurisprudence
;
standards
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Clinical Trials as Topic
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legislation & jurisprudence
;
standards
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Humans
;
Registries
4.Current Status and the Future of Occupational Safety and Health Legislation in Low- and Middle-Income Countries.
Safety and Health at Work 2018;9(4):365-371
This article addresses three key issues. First, the commonalities, differences, strengths, and limitations of existing occupational safety and health (OSH) legislation of low- and middle-income countries were determined. Second, required revisions were identified and discussed to strengthen the laws in accordance with the best international practice. Finally, proposals for additional OSH laws and interventions were suggested. A literature search of OSH laws of 10 selected low- and middle-income countries was carried out. The laws were subjected to uniform review criteria. Although the agricultural sector employs more than 70% of the population, most of the reviewed countries lack OSH legislation on the sector. Existing OSH laws are gender insensitive, fragmented among various government departments, insufficient, outdated, and nondeterrent to perpetrators and lack incentives for compliance. Conclusively, the legal frameworks require reformation and harmonization for the collective benefit to employees, employers, and regulatory authorities. New OSH legislation for the agricultural sector is required.
Clothing
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Compliance
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Jurisprudence
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Legislation as Topic*
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Motivation
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Occupational Health*
5.Clinical trial requests of indigenous diagnostic imaging ultrasound devices in first-time registration application.
Zhaojun GUO ; Guofang CAO ; Kan TAO
Chinese Journal of Medical Instrumentation 2012;36(6):438-440
This article introduces the clinical requests of indigenous diagnostic imaging ultrasound devices in first-time registration application and the clinical trial requests in Technical Review Guidance of Ultrasound Imaging Diagnostic Devices (category III) Registration and puts forward some questions of the guidance's implementation. It is hoped to help concerned people.
China
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Clinical Trials as Topic
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standards
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Device Approval
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legislation & jurisprudence
;
standards
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Guidelines as Topic
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Ultrasonography
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instrumentation
6.Use of Economic Evaluation in the Listing and Pricing of Pharmaceuticals.
Journal of Preventive Medicine and Public Health 2008;41(2):69-73
To curb a rapid increase in expenditures for pharmaceuticals, the Korean government introduced a positive list system and a negotiation process for drug prices at the end of 2006. Economic evaluation of pharmaceuticals has begun to have a pivotal role in the listing and pricing of drugs for the Korean National Health Insurance. There are some points to discuss regarding the use of economic evaluation in the listing and pricing in the context of the Korean system. First, the listing and pricing processes have been fragmented, evoking complaints from pharmaceutical companies and delaying the access of new drugs to patients. Second, there is a concern that the positive list system may limit the range and availability of drugs for patients to choose for treatment. Third, the time schedule for de-listing of existing drugs may not be realistic. Fourth, it is not always easy to provide reliable evidence of cost-effectiveness due to a lack of materials. Fifth, there is no consensus on the range of the ICER (incremental cost-effectiveness ratio) acceptable to the Korean society. In conclusion, in the near future, it will be necessary to evaluate the achievements that the economic evaluation has provided to the Korean society.
Cost-Benefit Analysis
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Economics, Pharmaceutical/legislation & jurisprudence/*organization & administration
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Formularies as Topic
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Humans
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Korea
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Legislation, Drug
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Pharmaceutical Preparations/*economics
7.Global patent overview of Ginkgo biloba preparation.
Xin-Min CHENG ; Hai-Min LEI ; Wei LIU
China Journal of Chinese Materia Medica 2013;38(17):2889-2893
With related global patent data as analysis samples, worldwide patent overview of Ginkgo biloba preparation is analyzed in application, applicant, technical distribution and so on. This research shows that the most important areas of G. biloba preparation are Europe and China. The European applicants start earliest along with developing smoothly, moreover, their patents have best quality. The Chinese applicants start late along with the fastest growing, and have already certain research capabilities, moreover, their patents' quality needs to be improved. This research result provides reference for development of G. biloba preparation. The author suggest that Chinese applicants learn techniques and layout experiences of other's patents fully to enhance the level of new drug development and patent protection.
Biological Products
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Chemistry, Pharmaceutical
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legislation & jurisprudence
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manpower
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methods
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organization & administration
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China
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Europe
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Ginkgo biloba
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chemistry
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Humans
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Patents as Topic
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legislation & jurisprudence
8.Strategy and core technologies for the secondary development of Chinese patent medicine.
Bo-Li ZHAGN ; Xiao-Hui FAN ; Yang LIU ; Hai-Bin QU ; Jun-Hua ZHANG ; Yi-Yu CHEGN
China Journal of Chinese Materia Medica 2013;38(22):3797-3800
Secondary development of Chinese Patent Medicine (CPM) is an effective and innovation-driven way for the leaping development of Chinese medicine industry with less investment and faster return. Aim to improving the efficacy, safety and batch-to-batch consistency of CPMs, the theory and methodology for the secondary development of CPMs, mode for cultivating superior CPM, approaches to reforming the pharmaceutical technology and the corresponding core technologies were proposed in this paper, which is summarized as 'One objective, Three analyses, Five definitudes and Seven improvements'.
Drugs, Chinese Herbal
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chemistry
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economics
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Patents as Topic
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Technology, Pharmaceutical
;
economics
;
legislation & jurisprudence
;
methods
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Translational Medical Research
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economics
;
legislation & jurisprudence
;
methods
9.Guidelines for Economic Evaluation of Pharmaceuticals in Korea.
Journal of Preventive Medicine and Public Health 2008;41(2):80-83
An economic evaluation is required in order to apply to the Health Insurance Review and Assessment Service (HIRA) for a listing in the national drug formulary. To assist companies in preparing the necessary documents, HIRA published guidelines for the economic evaluation of pharmaceuticals in 2006. The guidelines are composed of two parts: guidance an explanatory notes. Each guideline reflects the best practice which meets both the theoretical consensus within the academic community and local situations, like data availability. To enhance the transparency of evaluation, guidelines emphasize the reproducibility of data and analysis result. That is, all evaluation processes are required to be described in enough detail to be replicated by reviewers. With growing experience and theoretical development in this area, HIRA guidelines will be revised periodically.
Cost-Benefit Analysis
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Economics, Pharmaceutical/legislation & jurisprudence/*organization & administration
;
*Guidelines as Topic
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Humans
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Korea
;
Pharmaceutical Preparations/*economics
10.A Scopus-Based Analysis of Publication Activity in Kazakhstan from 2010 to 2015: Positive Trends, Concerns, and Possible Solutions.
Marlen YESSIRKEPOV ; Bekaidar NURMASHEV ; Mariya ANARTAYEVA
Journal of Korean Medical Science 2015;30(12):1915-1919
The article analyzes the publication activity of scientific authors from Kazakhstan based on Scopus and SCImago Journal & Country Rank data from 2010 to 2015. The number of indexed multidisciplinary and medical articles from the country has been steadily growing from 2011 onward and this can be due to the adoption of the new Law on Science in that year. Several regulatory legal acts have been issued in recent years aimed at improving the quality of local journals and the international recognition of academic degrees and titles. Publication activity of scientific authors from Kazakhstan was found to be higher than that from other countries in the Central Asian region. However, there are still many unresolved issues related to the English language barrier, lack of indexing status of local journals, and poor topical education on science writing and editing. As such, the number of articles published in 'predatory' journals remains sizable, and there are concerns over authors' negligence and plagiarism. The global solution to the discussed problems may be achieved by educating researchers, authors, reviewers, and editors.
Bibliometrics
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Humans
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Kazakhstan
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Language
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Periodicals as Topic
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Publications/ethics/legislation & jurisprudence/*trends
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Publishing/trends
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Scientific Misconduct