OBJECTIVE：To provide sugge stions for improving the variety of pediatric drugs and ensuring the safety of pediatric drug use in China. METHODS ：The historical evolution of laws and regulations on the marketing approval of pediatric drugs in the United States and the implementation results of relevant policies were summarized. Combined with the current situation of the development of pediatric drugs in China ，some suggestions were put forward to ensure the accessibility and safety of pediatric drug use in China. RESULTS & CONCLUSIONS ：Since 1994，the United States had issued a series of laws and regulations to encourage the development of pediatric drugs. At present ，the marketing approval of pediatric drugs were mainly based on the two laws of Best Pediatric Drug Act（BPCA）and Pediatric Research Equality Act （PREA）. From 1998 to 2019，the amount of supplements of pediatric drug information in drug instructions of the United States showed a fluctuating growth. As of April 2020，854 kinds of drugs had been modified in pediatric instructions ，792 of which had been carried out post marketing pediatric clinical research ，and the problem of incomplete pediatric instructions had also been greatly improved. At present ，China’s policies on pediatric drugs mainly included encouraging R&D innovation ，giving priority to review and approval ，and strengthening R&D technical guidance. Although certain achievements had been made ，there were still some problems ，such as imperfect policies and regulations ，and great difficulties carrying out pediatric drug clinical trials. It is suggested that our country should draw lessons from the American regulations on pediatric drugs ，pediatric research and the catalogue of pediatric drugs ，and establish a system and catalogue of ped iatric drug use suitable for China ’s national conditions ，so as to improve the effectiveness ，safety and accessibilityof pediatric drugs.

OBJECTIVE To explore the whole-process pharmaceutical care model of iodine contrast medium and promote the rational clinical use of iodine contrast medium. METHODS Clinical Professional Committee on Rational Drug Use of China Medical Education Association and Expert Committee on Drug Evaluation and Clinical Research of Guangdong Pharmaceutical Association organized domestic experts to establish a working group on the Consensus on the whole-process pharmaceutical care for iodine contrast medium. The working group conducted literature searches， evidence-based analysis， and discussions on the development process， indications， contraindications， adverse drug reactions， drug interactions， drug use for special population， pharmaceutical care， and other key topics to summarize the content and process of the whole-process pharmaceutical care for iodine contrast medium. This consensus was ultimately formed. RESULTS The consensus on whole-process pharmaceutical care for iodine contrast medium included an evaluation of the patient， renal function， combined drug use， and hydration regimen before examination， the presence of contrast agent extravasation or suspected acute adverse reactions during examination， observation time points and follow-up after examination， and the presentation of specific work in each stage through pharmaceutical care flowchart. The medication monitoring record form was also formed to record the work situation. CONCLUSIONS The consensus has established a whole-process pharmaceutical care system for iodine contrast medium， providing scientific evidence for clinical physicians and nursing staff in the rational use of such special drugs， and also serving as a reference for pharmacists in providing related pharmaceutical care.

In order to promote the rational clinical use of gadolinium-based contrast agents （GBCA） and to provide a reference for physicians to prescribe such contrast agents and for pharmacists to review prescriptions， the consensus working group launched the preparation project of “Consensus on whole-process pharmaceutical care for GBCA” according to domestic and foreign guidelines and consensus. The Zhujiang Hospital of Southern Medical University took the lead and cooperated with clinical experts and pharmaceutical experts from several domestic medical institutions to discuss and summarize the basic pharmacological effect of GBCA， types， pharmacokinetics， pharmacodynamics， indications， contraindications， precautions， usage and dosage， adverse drug reactions， and finally forms the consensus. The main contents of this consensus include an overview of various types of GBCA， rational clinical use of drugs， security management and whole-process pharmaceutical care process， etc.， for reference by physicians and pharmacists in medical institutions at all levels.

In Japan, a re-examination system was introduced in the 1970s, and Post-marketing surveillance (PMS) has been conducted in many cases after the launch of new drugs or the approval of new indications for existing drugs. The revised Good Post-marketing Study Practice (r-GPSP) was enacted in 1 April 2018, and more scientific approach has been required for PMS. The survey aims to identify what kinds of change occurred in the PMS planned after r-GPSP enacted. As for the study method, after confirming the review report of each product, Risk Management Plan (RMP), and the package insert, and extracting necessary items, tabulation and analysis were performed. As a result of analysis, Drug Use Investigations (DUI) still accounted for more than 60％ of the total in PMS. Regarding the target number of DUI, Fifty-eight out of 90 had a sample size of 500 or fewer, only 3 studies exceeded 3,000. Regarding the newly introduced Post-marketing database surveillance (DB study) after r-GPSP enacted, 13 products and 18 surveillances were confirmed, although the number was not as large as the number of DUI. The most used database was Medical Data Vision Co., Ltd. (MDV), which were used in twelve DB studies, and cardiovascular disease and interstitial pneumonia were set as survey targets for safety considerations in multiple studies. There was no Drug Use Comparative Investigation. Furthermore, there were two products which were approved on the condition with re-examination period but did not required additional Pharmacovigilance activities. In terms of sample size calculation, 88 out of 135 studies mentioned rationales for setting the number of samples. Of which, 58 studies had statistical rationales. In many studies, the sample size calculation method that was commonly used in conventional PMSs, called ‘Rule of three’ was described as the statistical rational. After r-GPSP enacted, newly introduced Post-marketing surveillance, including DB surveys, and the scientific approach recommended by PMDA have been adopted in companies gradually. In the future, in order to further promote the scientific approach, it is necessary to further improve the capability of human resources of companies involved in PMS.

The source of clinical evidence in drug development has been limited to be generated from clinical trials for many years. However, the evidence generation should be extended to Real World Data (RWD), which will play a key role anywhere. The ICH GCP renovation recommends selecting from a variety of clinical trial designs and data sources choices where innovative new drugs will be provided to patients as an earlier approval of the new drug application. In the early-stage approval system of the Ministry of Health of Labor and Welfare and the revision of GPSP in Japan, it is clearly stated that medical databases and patients' registry will be available. In this manuscript, we summarize the following cases of the utilizing RWD in drug development； (1) submitting data for a new drug application, (2) planning of clinical trials and patients' recruitment for clinical trials, (3) collecting clinical trial data using Electronic Health Record as data source, (4) assessing clinical outcomes and diagnosis, (5) developing strategies of drug development, drug pricing and access. Although there are many challenges in each application and the improvement in the infrastructure and regulatory environment is desired, we hope the progress of RWD use in the practice of drug development without waiting for that.

Objective：To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design：Web based-questionnaire surveyMethods：This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results：［Background］ Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5％) have “experienced in utilization of RWD”, and 12 (11.8％) have “experienced in considering utilization of RWD”. ［Utilization by RWD Type］ By data source, hospital-based claim data was the most frequently used (65 cases, 63.7％), followed by insurance-based claim data (61 cases, 59.8％), surveys (38 cases, 37.3％), and EMR (36 cases, 35.3％) in experienced RWD utilization. Conclusion：This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.

Objective：To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design：Web based-questionnaire surveyMethods：This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results：［Background］ Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5％) have “experienced in utilization of RWD”, and 12 (11.8％) have “experienced in considering utilization of RWD”. ［Utilization by RWD Type］ By data source, hospital-based claim data was the most frequently used (65 cases, 63.7％), followed by insurance-based claim data (61 cases, 59.8％), surveys (38 cases, 37.3％), and EMR (36 cases, 35.3％) in experienced RWD utilization. Conclusion：This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.

  China is one of the countries abundant in hot spring resources. There are more than 4,000 hot spring resources consisting of two types: the natural hot spring and the developed hot spring. Yet, there are still many more hot spring resources to be explored and developed.   To the end of 2013, there were around 1,000 hot spring tourism facilities or projects in operation. The yearly number of visitors to hot spring tourism facilities reached over 60,000,000 by the end of 2012.   Although China has a long history of taking hot spring as a gift the Nature for bathing and healing, in ancient China, hot spring was never integrated into the mainstream traditional Chinese medicine (TCM), medication and practices.   Thermalism and balneotherapy was introduced into China in 1920s.   In 1940, Professor Chen Yanbing (1903-1996), the founder of the modern thermalism and hot spring medicine of China (thanks to Japan, Prof. Chen Yanbing used to study in medical college where he studied hot spring medicine, Keio University during 1928-1932) published a book on hot spring and medicine. It was the first book of its kind in China. In 1959, he established the first medical institute on hot spring study at the medical school of Sun Yat- Sen University, Canton province.   Around the year of 1949, the concept of hot spring hospital (sanatorium) and thermalism was officially introduced into China from former Soviet Union and Eastern European socialist countries, and regarded as an important part of national healthcare system. The first hot spring sanatorium, now named Tanggangzi hot spring hospital, was soon opened in 1950, modeled after the hot spring sanatorium of Soviet Union.   At its heyday of the sanatorium business in 1980s, there were more than 300 hot spring sanatoria and hospitals all over China. Under the centralized social and economical plan system during 1950s to 1980s, all the sanatoria were state-owned and state-run.   When most of the sanatoria were falling down rapidly in mid 1990s, a new business model of hot spring so called hot spring tourism was rising and developing rapidly.   The hot spring tourism is a new product type that consists of different kinds and sizes of indoor and outdoor hot spring pools in man-made garden or natural landscaping surroundings, and it usually combines with hotel, restaurant, massage house, theaters, KARAOKE, water park, ski field and other entertainment facilities. The main purposes that visitors come to hot springs are relaxation, social activity, entertainment and health keeping.   Almost all the hot spring tourism facilities are commercially invested and operated, and none of them is integrated into social health system, or even commercial health system, thus they cannot be reimbursed at all.   During 1997 to 2012, hot spring tourism developed rapidly all over the country and became the mainstay of hot spring industry in China.   In 2009, China Hot Spring Tourism Association (CHSTA) was established under the China Tourism Association. Soon after the establishment, the association applied for joining FEMTEC and being approved in a short time, and became the vice chairman membership country of FEMTEC.   So far, CHSTA has co-organized together with the FEMTEC through two annual congresses of FEMTEC separately held in 2008 and 2012 in China. Because of the influences of the two congresses and CHSTA’s continuing promotion, the concept of modern Thermalism especially balneotherapy and climatology has been widely accepted by scholars, professionals, investors and managers from the whole hot spring industry.

The liver is the most common anatomical site for hematogenous metastases of colorectal cancer, and colorectal liver metastases is one of the most difficult and challenging points in the treatment of colorectal cancer. In order to improve the diagnosis and comprehensive treatment in China, the Guidelines have been edited and revised for several times since 2008, including the overall evaluation, personalized treatment goals and comprehensive treatments, to prevent the occurrence of liver metastases, improve the resection rate of liver metastases and survival. The revised Guideline includes the diagnosis and follow-up, prevention, MDT effect, surgery and local ablative treatment, neoadjuvant and adjuvant therapy, and comprehensive treatment, and with advanced experience, latest results, detailed content, and strong operability.
Chemotherapy, Adjuvant ; China ; Colorectal Neoplasms ; pathology ; Hepatectomy ; Humans ; Liver Neoplasms ; diagnosis ; secondary ; therapy ; Neoadjuvant Therapy ; Practice Guidelines as Topic