Dentists ; legislation & jurisprudence ; Humans ; Legislation as Topic ; Malpractice ; legislation & jurisprudence ; Medical Errors ; legislation & jurisprudence

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 ; chemistry ; economics ; Patents as Topic ; Technology, Pharmaceutical ; economics ; legislation & jurisprudence ; methods ; Translational Medical Research ; economics ; legislation & jurisprudence ; methods

Traditional Chinese medicine (TCM) and acupuncture has been gradually accepted by the mainstream society since the 1970s and has been rapidly expanding, accompanying the tide of Chinese immigration since the 1980s. Acupuncture legislation has been approved by the governments of 5 provinces in Canada between 1988 and 2014. After the acceptance of self-regulation, 5 corresponding colleges were established, one after another. The code of ethics and professional practice standard were developed by the Colleges. British Columbia (BC) became the first Canadian province to offer acupuncture treatments as a supplementary benefit for its Medical Services Plan premium assistance recipients beginning in 2008. The 5 colleges united to form the Canadian Alliance of Regulatory Bodies of Traditional Chinese Medicine Practitioners and Acupuncturists (CARBTCMPA) in the same year. The Entry-level Occupational Competencies for the Practice of TCM in Canada were developed by CARB-TCMPA in 2010. The Pan-Canadian registration examinations for acupuncturists, herbalists and TCM practitioners have been administered and scheduled since 2013. The Entry-level Occupational Competencies for Doctors of TCM were developed by College of Traditional Chinese Medicine Practitioners and Acupuncturists of British Columbia (CTCMA-BC) in 2014. It sketches the blueprint for future development of the TCM profession in Canada.
Acupuncture Therapy ; trends ; Canada ; Education, Medical ; Humans ; Legislation as Topic ; Medicine, Chinese Traditional ; trends

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 ; Economics, Pharmaceutical/legislation & jurisprudence/*organization & administration ; Formularies as Topic ; Humans ; Korea ; Legislation, Drug ; Pharmaceutical Preparations/*economics

Lipuma equates continuous sedation until death (CSD) to physician-assisted suicide/euthanasia (PAS/E) based on the premise that iatrogenic unconsciousness negates social function and, thus, personhood, leaving a patient effectively 'dead'. Others have extrapolated upon this position further, to suggest that any use of sedation and/or opioids at the end of life would be analogous to CSD and thus tantamount to PAS/E. These posits sit diametrically opposite to standard end-of-life care practices. This paper will refute Lipuma's position and the posits borne from it. We first show that prevailing end-of-life care guidelines require proportional and monitored use of sedatives and/or opioids to attenuate fears that the use of such treatment could hasten death. These guidelines also classify CSD as a last resort treatment, employed only when symptoms prove intractable, and not amenable to all standard treatment options. Furthermore, CSD is applied only when deemed appropriate by a multidisciplinary palliative medicine team. We also show that empirical data based on local views of personhood will discount concerns that iatrogenic unconsciousness is tantamount to a loss of personhood and death.
Analgesics, Opioid ; therapeutic use ; Attitude of Health Personnel ; Death ; Deep Sedation ; ethics ; Ethics, Medical ; Euthanasia ; ethics ; legislation & jurisprudence ; Humans ; Hypnotics and Sedatives ; therapeutic use ; Palliative Care ; ethics ; Personhood ; Philosophy, Medical ; Practice Guidelines as Topic ; Suicide, Assisted ; ethics ; legislation & jurisprudence ; Terminal Care ; ethics ; Unconsciousness

The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.
Guidelines as Topic ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing ; Risk Management ; methods ; United States ; United States Food and Drug Administration

In 2012, USA Food and Drug Administration (FDA) approved 39 new drugs, however, there are only two botanical drugs (one topical and one oral) approved by FDA since the publication of the FDA's industry guidelines for the botanical drug product in June 2004. The approval shows the Western guideline can be used for herbal medicines, authors investigate current regulation on herbal medicine clinical research, identify challenges conducting clinical trials, and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area. Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials. Authors critically explore case study of the 1st FDA approved botanical drugs, Veregen (sinecatechins), green tea leaves extract, a topical cream for perianal and genital condyloma. In consideration of current regulation environment in USA, based on the findings and analysis through the literature review and Veregen case study, authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considering in a herbal medicine clinical trial.
Biomedical Research ; legislation & jurisprudence ; Clinical Trials as Topic ; Herb-Drug Interactions ; Herbal Medicine ; legislation & jurisprudence ; Humans ; Plants, Medicinal ; adverse effects ; United States

OBJECTIVETo study current regional development and optimization schemes of patents of traditional Chinese medicine compounds.

METHODSimple statistics and cluster analysis were adopted for calculating application quantity, maintenance quantity and quantity of scientific research papers related to patents of traditional Chinese medicine compounds in different regions. On that basis, cluster analysis was used for studying current development patents of traditional Chinese medicine compounds in different regions.

RESULTThe 34 regions, including Chinese mainland, Hong Kong, Macau and Taiwan, were divided into four groups by cluster analysis according to the difference in quantities of patents and research papers. The first and third region are better, the second region is medium, while the forth region is not ideal.

CONCLUSIONDifferent regions shall adopt suitable development schemes for the development of traditional Chinese medicine compounds according to their actual situations. Reasonable regional alliance is helpful for inter-regional win-win and co-flourishing.

Chemistry, Pharmaceutical ; legislation & jurisprudence ; standards ; China ; Cluster Analysis ; Drug Therapy ; Drugs, Chinese Herbal ; chemistry ; standards ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; standards ; Patents as Topic ; legislation & jurisprudence

SCHWABE Company in German is the first and largest manufacturer of Ginkgo biloba preparation. The company not only has leading technology in this field, but also protects its own market effectively through the high quality of patent drafting and exactly patent layout. Based on multi-angle analysis for patent portfolio of G. biloba preparation at application time, legal status, globally layout, Chinese layout, the article provides technical reference of research and development of G. biloba, also provides valuable experience of traditonal Chinese medicine patent portfolio layout for Chinese enterprises.
Drug Industry ; economics ; legislation & jurisprudence ; trends ; Ginkgo biloba ; chemistry ; Humans ; Patents as Topic ; legislation & jurisprudence ; Phytotherapy ; economics ; trends ; Plant Preparations ; isolation & purification ; Technology, Pharmaceutical ; economics ; trends

The ageing population is posing new challenges to Singapore's healthcare system. The rise of dual income and the decline of extended families, as well as an increase in age-related degenerative disorders due to increased longevity render it difficult for the family to remain the primary social safety net to care for our elderly in their own homes. Consequently, nursing homes may become increasingly relevant for resource and expertise-challenged families to cope with the burden of caring for a frail and dependent elderly. However, as the recent Nightingale Nursing Home elderly mistreatment incident attests, the standards of some have been found wanting. This paper will trace the history of nursing homes in Singapore and the evolution of government policies towards them, discuss the challenges and trade-offs of nursing home regulation, and provide suggestions for better care and governance.
Aged ; Forecasting ; Guidelines as Topic ; History, 20th Century ; History, 21st Century ; Humans ; Nursing Homes ; history ; legislation & jurisprudence ; standards ; trends ; Singapore