The ethic in pharmaceutical practice must comprised supply many drug, enough kinds, good drug, rapid, timely, accuracy with good service attitude, guarantee safely, sensibly price and drug must have good effect in treatment and prevention. From steps of cultivation, processing, export-import, supplying, drug preservation, control, analysis to drug user, all steps must express ethics of pharmaceutical practice
Ethics, Medical ; Drug and Narcotic Control

China ; Drug and Narcotic Control ; methods

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.
Australia ; Canada ; Delivery of Health Care ; Drug and Narcotic Control ; Drug Approval ; European Union ; Health Expenditures ; Japan ; Korea ; Nonprescription Drugs*

To better standardize clinical standard of medicinal materials and cut crude drugs in Chinese Pharmacopoeia (2010 edition, Volume I) and finish compiling work of relevant matching book named Clinical Guide to the Chinese Pharmacopoeia, based on analyzing the problems in clinical standard of medicinal materials and cut crude drugs in Chinese Pharmacopoeia (2005 edition, Volume I), feasibly practicable revising suggestion of standardizing clinical standard of medicinal materials and cut crude drugs in Chinese Pharmacopoeia (2010 edition, Volume I) is proposed.
China ; Drug and Narcotic Control ; Drugs, Chinese Herbal ; standards ; Pharmacopoeias as Topic

Drug and Narcotic Control ; Humans ; Marijuana Abuse ; Medical Marijuana ; Singapore

If the presence of residual solvents in pharmaceuticals exceeds tolerance limits as suggested by safety data, they may be harmful to the human body or the environment. It is because of this that the determination of residual solvents receives a great deal of attention. This paper reviews in detail the changes in the regulations on residual solvents in pharmaceuticals in leading pharmacopoeias, and the advances in the techniques involved, especially, the recent advances in the analytical techniques are summarized. At the end, the authors introduce the prospect of the expert system for determining residual solvents in pharmaceuticals based on the studies of their research group.
Capillary Electrochromatography ; Chromatography, Gas ; Drug Contamination ; prevention & control ; Drug and Narcotic Control ; Pharmaceutical Preparations ; chemistry ; Quality Control ; Solvents ; analysis

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 paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China's actual conditions, and cooperating with multidisciplinary researchers.
China ; Developed Countries ; Drug and Narcotic Control ; Guidelines as Topic ; Product Surveillance, Postmarketing

The FTIR method was used to investigate the correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test. The similarity of bacteria in the contaminated drug and environmental microbes was compared by critical hit value method and cluster analysis method. This constructed the FTIR spectra library of clean room environmental microbe, and determined the criterion to promptly judge if the bacteria isolated from pharmaceuticals were contaminated by environment or not, hence the exactness of "one-off report" of sterile test result can be guaranteed, and can be used for the dynamic monitoring of environmental bacteria of clean room. The method is proven to be simple, accurate and rapid, and can be easily spread to the pharmaceutical microbial control.
Bacteria ; isolation & purification ; Cluster Analysis ; Drug Contamination ; Drug and Narcotic Control ; Environment, Controlled ; Environmental Microbiology ; Spectroscopy, Fourier Transform Infrared ; methods

The article briefly introduces the status of the supervision and administration of Chinese herbal medicine, and summarizes the problems existing in the process of supervision and management. Meanwhile provides the countermeasures and suggestions of strengthening the supervision and administration of Chinese herbal medicine.
China ; Drug Contamination ; legislation & jurisprudence ; prevention & control ; Drug and Narcotic Control ; Drugs, Chinese Herbal ; chemistry ; standards ; Medicine, Chinese Traditional ; standards ; Quality Control