Herbal products are the mainstay treatment among patients with limited access to conventional medicines and those seeking holistic modalities for health and wellness. Usage continues to increase globally with the growing engagement of science and technology in the scientific and sound development of herbal products. In the Philippines, legislative controls on herbal medicine were established through the creation of the Philippine Institute of Traditional and Alternative Health Care (PITAHC) which aims to include herbal medicine use in the national health care system. This paper aims to review the current regulatory policies on production, registration, promotion, and use of herbal medicines in the country. Current policies provide measures in regulating, implementing, and monitoring of herbal medicines from production to consumption stages. However, improvements based on provisions from international standards can be adopted to guarantee efficacy and safety for public use. Policies are still lacking regarding implications of long-term effects; efficacy on specific populations (i.e. children, elderly, pregnant women); and on potential interactions with other food and drugs. There is also a need to strengthen studies on the environmental determinants influencing the effectiveness of herbal products. Paucity on studies on the cost-effectiveness of herbal medicines is further noted.

Plant ; Complementary Therapies ; Herbal Medicine ; Herbal Medicine--legislation & ; Jurisprudence

In order to prove safety and efficacy, herbal medicines must undergo the rigorous scientific researches such as pharmacokinetic and bioavailability, before they are put on the market in the foreign countries. Botanical Drug Products promulgated by the US FDA could guide industry sponsors to develop herbal drugs, which was also an important reference for investigating Chinese herbal medicines. This paper reviews and discusses novel approaches for how to assess systemic exposure and pharmacokinetic of Chinese herbal medicines, which were in line with FDA guidance. This mainly focus on identifying pharmacokinetic markers of botanical products, integral pharmacokinetic study of multiple components, Biopharmaceutics drug disposition classification system, and population pharmacokinetic-pharmacodynamic study in herb-drug interaction.
Animals ; Biomarkers, Pharmacological ; Drugs, Chinese Herbal ; chemistry ; pharmacokinetics ; Herb-Drug Interactions ; Herbal Medicine ; legislation & jurisprudence ; Humans

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

Over the past 30 years, China has significantly improved the drug development environment by establishing a series of policies for the regulation of new drug approval. The regulatory system for new drug evaluation and registration in China was gradually developed in accordance with international standards. The approval and registration of TCM in China became as strict as those of chemical drugs and biological products. In this review, TCM-based new drug discovery and development are introduced according to the TCM classification of nine categories.
China ; Drug Discovery ; legislation & jurisprudence ; standards ; Drugs, Chinese Herbal ; analysis ; standards ; Medicine, Chinese Traditional ; standards

In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China's drug regulatory agency, and put forward relevant suggestions. Although China's drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.
China ; Drugs, Chinese Herbal ; Legislation, Drug ; Medicine, Chinese Traditional ; Pharmaceutical Preparations

Patent technology is regarded as technological trends under the market economy condition. The case showed the information form patent literature can be widely used in technology or economy. In this study, we analyzed the patent technology status quo and development trend for Chinese herbal medicines based on China patent database. The patent technology status quo is divided from the technology of biotechnology, quality control, cultivation and herb processing on Chinese herbal medicines. Furthermore, some recommendations of technology development and advices on patent protection for Chinese herbal medicines were suggested.
China ; Drugs, Chinese Herbal ; chemistry ; Herbal Medicine ; legislation & jurisprudence ; trends ; Humans ; Patents as Topic ; Plants, Medicinal ; chemistry ; genetics ; Quality Control

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

Under the background of the new medical reform, a large variety of traditional Chinese medicine from complicated sources, Chinese traditional medicine of actor of true and false of the quality directly affect the drug safety and clinical efficacy, but also relate to the social and economic benefits of hospital. Along with the development of the modern management of medical institutions and drug circulation circulation system reform in our country, the hospital drug inventory, supply and management work is an important topic for the pharmaceutical trading. However, there is always contradiction, dispensary need to supple pharmacy, in order to satisfy the demands of hospital patients with normal diagnosis and treatment work. However, if the drug inventory is too much, not only increases the drug monitoring problem, at the same time, but also causes storage costs rise. Therefore, completing scientific and reasonable storage and management becomes urgent problems at present. Wherefore, our country administration of traditional Chinese medicine in 2007 promulgated the "Chinese traditional medicine yinpian management norms in hospital", aims to standardize management of Chinese traditional medicine quality and improve the safety of drugs. The author through looking up information and visiting survey, to understand the currently existing problems, and summarizes the literature inland and abroad in recent years Chinese medicine drug inventory management work experience, in view of status quo of Chinese medicine inventory management in China, put forward the solution. To guarantee TCM pharmacy management more standardized, more standard, to adapt to the new reform of Chinese traditional medicine industry, improve the management level of hospital, defend the hospital's reputation and the patient's interests.
Drugs, Chinese Herbal ; supply & distribution ; Humans ; Inventories, Hospital ; economics ; legislation & jurisprudence ; Medicine, Chinese Traditional ; economics ; standards ; Quality Control ; Safety

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