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

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

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

Since the positive listing system for prescription drug reimbursement has been introduced in Korea, the number of pharmacoeconomic evaluation studies has increased. However it is not clear if the quality of pharmacoeconomic evaluation study has improved. Due to the lack of randomized clinical studies in Korean health care setting, Korean economic evaluation studies have typically integrated the local cost data and foreign clinical data. Therefore methodological issues can be raised in regard to data coherence and consistency. But the quality of data was not questiened and the potential bias has not been investigated yet. Even though changes in policy have encouraged the undertaking of pharmacoeconomic evaluations, there is few public-side funding for validation study of cost-effectiveness models and data. Several companies perform economic evaluation studies to be submitted on behalf of their own products, but do not want the study results to be disclosed to the academic community or public. To improve the present conduct of pharmacoeconomic evaluations in Korea, various funding sources need to be developed, and, like other multidisciplinary areas, the experts in different fields of study should collaborate to ensure the validity and credibility of pharmacoeconomic evaluations.
Cost-Benefit Analysis ; Economics, Pharmaceutical/legislation & jurisprudence/*organization & administration ; Formularies as Topic ; Humans ; Korea ; Pharmaceutical Preparations/*economics ; Technology Assessment, Biomedical

Current patent protection of traditional Chinese medicine (TCM) compounds is far from being satisfactory with increasing research and development achievements. As patent protection of traditional Chinese medicine compounds is closely related with many fields such as research and development of new TCM drugs, industrial development and TCM internationalization, the development of research and harmonious development of TCM compounds and their patent protection is bound to have a far-reaching influence on domestic and even international societies.
Chemistry, Pharmaceutical ; economics ; legislation & jurisprudence ; China ; Drugs, Chinese Herbal ; chemistry ; economics ; Humans ; Medicine, Chinese Traditional ; economics ; Patents as Topic

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

INDENA SPA Company in Italy is a multi-national company that produces and sells plant extracts. Based on its own re- search advantages in the field of Ginkgo biloba preparation, the company protects its own products market effectively through building patent portfolio around the patents of its opponent. Based on the multi-angle analysis for patent portfolio of G. biloba preparation from the aspects of application time, legal status, technical development route, and patent portfolio layout, this article provides technical reference on research and development of G. biloba preparation, and the author suggest that Chinese applicants learn techniques and layout experiences of other patents fully to enhance the level of research and patent protection level.
Chemistry, Pharmaceutical ; economics ; legislation & jurisprudence ; Ginkgo biloba ; chemistry ; Italy ; Patents as Topic ; Plant Extracts ; chemistry ; economics ; isolation & purification

"Fifteen" since, our country Chinese traditional medicine industry science and technology has made remarkable achievements. In this paper, the development of science and technology policy, Chinese medicine industry, platform construction and other aspects were analyzed, showing 10 years of Chinese traditional medicine industry development of science and technology innovation achievement and development, and on the current development of traditional Chinese medicine industry facing the main tasks and guarantee measures are analyzed.
China ; Drugs, Chinese Herbal ; economics ; history ; standards ; History, 21st Century ; Humans ; Patents as Topic ; Technology, Pharmaceutical ; economics ; history ; legislation & jurisprudence ; trends