The cancer therapies currently available do not yet offer fully satisfactory treatments, even in 21st century, and efforts and progress are being made daily in the area of drug development. Anticancer drugs, which play the leading role in cancer therapy, are being developed dynamically around the world, and Japan is not an exception. Looking back on the history of developing anticancer drugs, cytotoxic drugs were the mainstream of drug development until the end of the 20th century. In the 21st century, they have been replaced by molecularly targeted drugs, and thus the development of cytotoxic drugs has been declining rapidly. There were various approaches to the development of anticancer drugs and clinical trial endpoints until the 1980s. In 1991, the "Guidelines for Clinical Evaluation Methods of Anti-Cancer Drugs in Japan" was issued. From 2000 onwards, there was vigorous discussion on the clinical trial endpoints of anticancer drugs in the United States. In conjunction with this discussion, the "Guidelines for Clinical Evaluation Methods of Anti-Cancer Drugs in Japan" was revised in 2005. The revised guidelines required survival data at the time of filing a new drug application (NDA) as a general rule. Around 2005, a bridging strategy was promoted as the "International Conference on Harmonization E5" was promulgated among Japan, the U.S. and EU, resulting in an outflow of clinical trials to overseas, with more non-Japanese survival data generated outside of Japan used for NDAs than Japanese data. Subsequently, the "Guideline for Basic Principles on Global Clinical Trials" was issued in 2007, which promoted the change in the mainstream approach from a bridging strategy to a pivotal, global study involving Japan. Thus, an era of full-fledged globalization in clinical trials began. We believe Japan will need systems to enhance the motivation for anticancer drug development, such as an expedited program or pediatric program, from now on. We hope that the enhancement of these systems will contribute to shortening the period required for approving an anticancer drug and reducing developmental costs. Furthermore, we expect Japan to be creating breakthrough anticancer drugs in the near future.
The original formulation for "Tusujiu," which Japanese people still consume on the morning of January 1st, was created by Hua Tuo, but has not been studied in detail. The book Huatuo Shenyi Bizhuan, found in 1918, describes a concoction, "Biyijiu," that shows great similarity to the current Tusujiu; the ingredients for Biyijiu being rhubarb, atractylodes rhizome, cinnamon bark, platycodon root, zanthoxylum fruit, processed aconite root and smilax rhizome. The procedures for preparing and drinking it are to "pound the ingredients and then put them into a silk bag dyed with madder. During the daytime of the last day of the year, hang the bag in a well to soften the powder. Take the bag out early in the morning of the next day, the first day of the year. Heat the bag in fermented liquor until simmering. Drink the liquid with all family members, doing so while facing east. If one person drinks it, there will be no disease in the family. If the whole family drinks it, there will be no disease in their neighborhood in an area of one square 'li'. In this study, to determine the original formulation for Tusujiu, we examined a number of ancient medical texts from the 3rd to the 13th century that discuss Biyijiu and Tusujiu. As a result, we concluded that "Biyijiu" is likely to be the original formulation developed by Hua Tuo.
For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the "What," "How" and "Why" format. Finally, future proposals for the next decade are also outlined.
“Terumeru” was a patent medicine that an apothecary in Osaka sold as an expectorant and medicine for internal diseases towards the end of the Edo era. Due to its manufacturer, Gengendo, closing its expectorant business in the early Meiji era, further details are unknown. The author investigated Terumeru products dating back approximately 200 years. The objective of this study is to clarify what kind of patent medicine Terumeru was, and furthermore, compare it to other medicines with names spelled using katakana that were distributed around the same time as a topic of discussion. The characteristics of Terumeru were as follows : the dosage form was three times as much as that prescribed for similar drugs ; and although it was said to be of Dutch origin, the name of a Chinese clinician, Zhu Zhenheng, was cited on its efficacy statement and advertising. These findings revealed that there were problems with its formulation and inconsistency in its brand image. These reasons led to the conclusion that Terumeru was considered a katakana-named patent medicine during the pioneering days of pharmacology Japan.
Bad breath is a topic of general interest. In this study, the treatment for bad breath in traditional Chinese medicine was reviewed with a special focus on pathologic diagnosis and crude drug prescriptions. It was shown that bad breath developed based on both systemic and local diseases. Some systemic conditions, including nasal, paranasal, pulmonary and digestive diseases, are considered to cause bad breath. The morbid state of a patient with bad breath has been recognized as being based on "heat syndrome" and "Qi-stagnation syndrome." Bad breath based on "heat syndrome" is manifested as thirst and ulceration of the oral cavity, and has been treated with crude drugs such as Coptis rhizome, Scutellaria root and gypsum. One case study reported that bad breath resulting from a dry mouth was treated with byakkokaninjinto, a Kampo formulation containing gypsum. "Qi" is considered to be the vital energy of all life forms including for the functioning of organs and mental and emotional activity. "Qi-stagnation syndrom," referring to the dysfunction of organs, is manifested as psychosomatic symptoms such as irritability, a flushed face and restlessness. Bad breath based on "Qi-stagnation syndrome" has been treated with crude drugs such as Cnidium rhizome, clove and cinnamon bark. Modern dental and medical treatment both accept the participation of psychogenic agents in the development of bad breath. Bad breath also develops based on periodontal and oral diseases. This type of bad breath has been treated with mouth-wash (collutorium) containing Asiasarum root, Angelica dahurica root and Cnidium rhizome. This historical evidence regarding crude drug prescriptions contributes to the development of mouth care products for preventing and treating bad breath.
In China, present-day, the tree peony is not only being used in traditional medicine, but has also been extolled to a status equivalent to that of a national flower. This plant is now called mudan in the Chinese language, although it seems disputable what plant mudan originally referred to. Particularly, the botanical accounts on mudan in the Newly Revised Canon of Materia Medica (Xinxiu Bencao) contain some discrepancies regarding the actual features of the tree peony. The primary investigation of this issue has already been published, and reached the conclusion that mudan used to refer to Ardisia spp. However, further verifications looking at different aspects are required. This paper intends to show that mudan and Ardisia ssp. have shared drug properties and usages as listed in various Chinese medical texts. These consistencies certify that mudan can possibly be replaced with Ardisia ssp., when we utilize the pre-Tang dynasty's prescriptions. In addition, there is further significant evidence for the notion that mudan used to refer to Ardisia ssp.
Morizo Ishidate was born in the city of Aomori on January 24, 1901, the third son in his family. As the 16th Director General of the NIHS, he announced his decision to reform the organization and implemented this action in 1966. In September 1970, as the president of the Central Pharmaceutical Affairs Council, he decided to stop the use of all quinoform preparations. On May 21, 1973, he held a historic talk with Dr. Taro Takemi. After the meeting, the separation of dispensing and prescribing functions opened a new chapter in pharmaceutical history. Such a heroic and noble life may be due to his faith. In April 1922, he entered “Doushikai,” a dormitory belonging to Tokyo Imperial University. Yoshinosuke Konishi was his best friend in the dormitory. They joined a bible class directed by an American missionary, Miss Laura J. Maukʼ. In September 1947, at the age of 49, Yoshinosuke decided to devote the rest of his life to being an evangelist. After that time, Morizo supported him for 33 years. At the age of 70, Morizo confessed his belief of Jesus Christ’s resurrection from the dead based upon following words in the bible, “Therefore, if anyone is in Christ, he is a new creation. The old has passed away; behold, the new has come,” (2 CORINTHIANS 5 : 17). On July 18, 1996, he passed away at the age of 95.
This publication, commemorating the sixty years since the founding of Japan Society for the History of Pharmacy (JSHP), provides an overview of the Japanese pharmaceutical industry over a thirty-year span from 1980 to 2010. In the first section, entitled Medical Evolution: The Growth Period for Pharmaceutical Products, and the second section, "Patient-Based Medicine: The Period of Information Prioritization, the following themes are examined. Changes in Drug Pricing Policies, Promotion of Bungyō (separation of prescription from dispensing), Measures to Improve the Safety of Pharmaceutical Products; Appropriate Use of Pharmaceutical Products, Drug Discovery: Changes in Pharmaceutical Product Development and Actual Conditions in the Domestic Launch of New Medicines; Marketing (Medical Representative) Reforms, Pharmaceutical Industry Mergers and Acquisitions, Internationalization of the Pharmaceutical Industry. The following papers are provided as further references to support the conclusions made in the sections above. Changes in Japanese Drug Discovery Technologies and Drug Development. Japan's Pharmaceutical Market and Shifts in Manufacturing and Sales. Changes in Clinical Trials in Japan and Appropriate Use of Pharmaceuticals. Internationalization of the Japanese Pharmaceutical Industry.
In 1970s, the material patent system was introduced in Japan. Since then, many Japanese pharmaceutical companies have endeavored to create original in-house products. From 1980s, many of the innovative products were small molecular drugs and were developed using powerful medicinal-chemical technologies. Among them were antibiotics and effective remedies for the digestive organs and circulatory organs. During this period, Japanese companies were able to launch some blockbuster drugs. At the same time, the pharmaceutical market, which had grown rapidly for two decades, was beginning to level off. From the late 1990s, drug development was slowing down due to the lack of expertise in biotechnology such as genetic engineering. In response to the circumstances, the research and development on biotechnology-based drugs such as antibody drugs have become more dynamic and popular at companies than small molecule drugs. In this paper, the writers reviewed in detail the transitions in drug discovery and development between 1980 and 2010.
“Yakumi” and “Ryouri” are common vocabulary in modern Japanese. However, examples of their usage in terms of the Japanese meaning have not been found in general Chinese classics. Rather, conventionally they have been understood as kanji vocabulary originating in Japan. Therefore, through investigating and examining the sources and examples of both words, I found that they were derived from the original meanings of the Chinese words both in China and Japan, and the current meanings were adopted in Japan. It is very interesting to study the history of pharmacy and see in the processes and background that food was considered as a drug.
This paper is part 10 of a historical article on young students from Hyuga who went to Osaka or Kyoto to study in the Edo period. The article investigates the influence of these students on medical and pharmaceutical sciences in the Hyuga, which is now Miyazaki-Prefecture. The knowledge in this area is limited, thus, we aimed to examine and summarize the historical events. It was found that seven students, Bunchu Niizuma, Shikan Kai, Kaneo Niizuma, Ritsukei Shiraishi, Bunkichi Maki, Genzou Katayose and Buntetsu Kai, studied under Sanyou Rai in Osaka, and two students, Zusho Hayakawa and Chikanaga Nyuta-Motonaka, studied under Toyou Yamawaki in Kyoto. Both Kaneo Niizuma and Zusho Hayakawa participated in the foundation of the medical school called "Meidou-kan" at Nobeoka in 1857 before the Meiji Restoration in 1868.
After the long isolation in the Edo era, the new Meiji government tried to import science and culture from western countries. In the field of medical science, Kanpo, Chinese medicine, was abolished and western medicine was introduced in Japan. A medical system was established in 1874, but the division of prescribing medicines and dispensing them had not been introduced yet, and this situation prevented the increase in newborn pharmacists and solid pharmaceutical education for a long time. However, when the division of prescribing and dispensing medicines started in the late 1980s, the demand for pharmacists increased and a six-year pharmaceutical education system was introduced in 2006. The core curriculum that was established about 10 years ago had many problems, but the system was revised in 2013. The goal of the efforts is to improve the situation regarding the quality, quantity and contents of clinical pharmaceutical education for the new generation of pharmacists to come over the next 10 years. It is important to look at the pharmaceutical education of Japan in light of that of France, where the division of prescribing and dispensing medicine, and the pharmacy itself had been established in medieval times, focusing on the history of the educational system and requirements for pharmacists.
In China, the crude drug licorice ("kanzo" in Japanese, "gancao" in Chinese) has been used both dried and roasted as the situation demands from ancient times. The meaning of "roasted licorice" is simply roasted and honey-roasted in ancient and modern times, respectively. However, it is not clear medicinal purposes of processed licorice or why licorice processed with honey began to be used. We researched ancient literature and found that the main objective of roasting was to change the property of licorice from cool to warm (i.e., dried licorice had the effect of draining fire), while roasted licorice was used as an energy supplement, having a digestive effect and thus warming the body. Meanwhile, doctors began using honey-roasted licorice to treat throat pain from the Song dynasty, and then at the end of the Qing dynasty, honey-roasted licorice was expected to have the same effects of roasted licorice (i.e., supplementing energy and having a digestive effect).
Cinchona is known as a magic bullet for malaria and its cultivation was dominated by Java on a global scale in the 19th century. In 1875, in accordance with a suggestion by Takeaki Enomoto, the Meiji government made a request to the Dutch government that cinchona seedlings be distributed to Japan. In response to that request, in 1876, 42 cinchona seedlings arrived in Yokohama from Java. It was the first time cinchona seedlings were shipped to Japan. After that, cinchona seeds and seedlings were shipped to Japan a total of three times between 1876 and 1883. The seeds shipped in 1878 were raised at the Nishigahara Agricultural Experiment Station and then planted at nine places in both Okinawa and Kagoshima Prefectures in 1882. The planter was Yasusada Tashiro. However, all of the planted seedlings had died by 1884. The first national farming plan of cinchona in Japan ended in failure. These matters were found in documents included in Nomutenmatsu compiled by the Ministry of Agriculture and Commerce of the Meiji government in 1888.
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When planning pharmaceutical packaging, the package size for the product is important for determining the basic package concept. Initially, the sales unit for herbal medicines was the weight; however in 1868, around the early part of the Meiji era, Japanese and Western units were being used and the sales unit was confusing. Since the Edo era, the packing size for OTC medicines was adopted using weight, numbers, dosage or treatment period. These were devised in various ways in consideration of convenience for the consumer, but the concept was not simple. In 1887, from the time that the first edition of the Japanese Pharmacopoeia came out, use of the metric system began to spread in Japan. Its use spread gradually for use in the package size of pharmaceutical products. At the time, the number of pharmaceutical units (i.e., tablets), became the sales unit, which is easy to understand by the purchaser.
In our previous research, we have found that the function of some herbs differs according to ancient and present records. The reason is thought to be that the plants are different in spite having of the same name. In addition, the original herbs for some specific herb names cannot be understood. This paper attempts to clarify the details of herbs named Chang.
Summary Early Meiji Japan witnessed a boom in Japanese Ginseng exports, but the years between 1880 and 1886 brought a sharp decline. Previous research linked this recession to chaos in domestic production and by illegal imports of Korean Ginseng without presenting data about the actural fluctuation of Ginseng output. Moreover, as the biggest target market of Japanese Ginseng exportation, the situation in Qing, China should be included in any analysis. Based on statistical data collected in China and Japan, this study clarifies the reasons for the sharp decline during the early 1880s.