No abstract available.
Korea* ; Legislation, Drug*

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

Following more and more new drugs are authorized into market, new, serious or unexpected adverse drug reactions appear frequently, which is a serious threat to people health and life. Through making laws and guidelines, governments of various countries aim to strengthen and standardize the surveillance and reporting of postmarketing drugs. The drugs management department of our country are doing related jobs positively, but there are some problems, such as drug risk-menagement is not emphasized well, and the management department lacks clarity on operating related regulations. This article tries to explore foreign countries' laws and regulations on the surveillance and reporting of postmarketing drugs, aiming to provide reference for our courtry.
Adverse Drug Reaction Reporting Systems ; legislation & jurisprudence ; organization & administration ; China ; Humans ; Internationality ; legislation & jurisprudence ; Legislation, Drug ; Marketing of Health Services

The rationality of current validity period of the preparations in medical institutions was analyzed. Based on the discussion of the main functions of the validity period in administration admission and the essential principles for the reasonable enactment of the validity period, author suggested that the validity period should be amended as 5 years in order to exert more effectively on administration admission of the preparation of medical institution.
China ; Drug and Narcotic Control ; legislation & jurisprudence ; Health Facilities ; legislation & jurisprudence ; standards

This article discusses the characteristics of cmmunity herbal monographs for traditional herbal medicinal products and its establishment procedure. It also reviews the new development of cmmunity traditional herbal monographs. The purpose is to clarify the relationship between cmmunity herbal monographs and simplified registration for traditional herbal medicinal product in European Union and provide reference to the registration of taditional Chinese mdicinal products in Europe.
Drug Approval ; legislation & jurisprudence ; European Union ; Humans ; Phytotherapy ; Plants, Medicinal

In 1999, the Korean government made a drug pricing policy reform to improve the efficiency and transparency of the drug distribution system. Yet, its policy formation process was far from being rational. Facing harsh resistance from various interest groups, the government changed its details into something different from what was initially investigated and planned. So far, little evidence supports any improvement in Korea's drug distribution system. Instead, the new drug pricing policy has deteriorated Korea's national health insurance budget, indicating a heavier economic burden for the general public. From Korea's experience, we may draw some lessons for the future development of a better health care system. As a society becomes more pluralistic, the government should come out of authoritarianism and thoroughly prepare in advance for resistance to reform, by making greater efforts to persuade strong interest groups while informing the general public of potential benefits of the reform. Additionally, facing developing civic groups, the government should listen but not rely too much on them at the final stage of the policy formation. Many of the civic groups lack expertise to evaluate the details of policy and tend to act in a somewhat emotional way.
Drug Costs/*legislation & jurisprudence ; Health Care Reform/*economics/*legislation & jurisprudence ; Humans ; Korea ; National Health Programs/economics/legislation & jurisprudence ; *Politics ; *Public Opinion

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

This paper studied the status of registration administration of extracts of traditional Chinese medicine (TCM) and its preparation, discussed some factors which affect the quality of extracts of TCM and its preparation, and puted forward some suggestions to strengthen the registration administration of extracts of TCM and its preparation such as clear positioning and legal basis, improving and enhancing quality standards, implementing of record management and so on.
Chemistry, Pharmaceutical ; legislation & jurisprudence ; standards ; China ; Drugs, Chinese Herbal ; standards ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional ; standards

OBJECTIVETo provide references for the evolvement of medical devices labeling and manual administration in China,

METHODSBy content analysis, 10 juristic documents relevant to device labeling and manual were collected from FDA website, compared to which, the federal regulation was mainly analyzed.

RESULTSThere are five main differences of device labeling regulation between U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice,

CONCLUSIONSA set of comprehensive juristic system for device labeling has been established by FDA. from which China should draw experience, to administrate the prescription devices and the over-the-counter devices in classification, and set up device labeling guidance, thus guarantee the safety and efficacy of device.

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