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.

Chronic hepatitis B(CHB)is still a major public health issue in China,and without effective control,it can further progress to liver cirrhosis and liver cancer,bringing huge social and economic burdens.At present,antiviral therapy is the main treatment method for CHB,and integrated traditional Chinese and Western medicine therapy is the characteristic treatment method for CHB in China and can improve clinical efficacy by complementing each other's advantages.In order to promote the concept integrated traditional Chinese and Western medicine collaborative diagnosis and treatment,facilitate the development of integrated traditional Chinese and Western medicine diagnosis and treatment techniques for CHB,and establish standardized disease diagnosis and treatment regimens,Expert Committee on Hepatology in Doctor Society of Integrative Medicine,Chinese Medical Doctor Association,established a consensus expert group to discuss and formulate Expert consensus on integrated traditional Chinese and Western medicine diagnosis and treatment of chronic hepatitis B,which elaborated on the concept of integrated traditional Chinese and Western medicine collaborative diagnosis and treatment from the four aspects of CHB epidemiology,pathogenesis and etiology,integrated traditional Chinese and Western medicine diagnosis and syndrome differentiation,and integrated traditional Chinese and Western medicine therapy and proposed related recommendations,in order to improve the prognosis and quality of life of CHB patients.

Primary biliary cholangitis(PBC)is a chronic autoimmune liver disease.In recent years,related studies in China and globally have provided some evidence-based medical evidence for the integrated traditional Chinese and Western medicine treatment of PBC.Based on the latest diagnosis and treatment experience and guidelines in China and globally,Expert Committee on Hepatology,Doctor Society of Integrative Medicine,Chinese Medical Doctor Association,organized related experts in China to formulate this consensus,in order to provide guidance and reference for clinicians in the diagnosis,TCM syndrome differentiation,and integrated traditional Chinese and Western medicine treatment of PBC.

Corona virus disease 2019(COVID-19)infection has become a major public health issue affecting human health.The main goal of epidemic prevention and control at the current stage in China is to"protect people's health and prevent severe cases".Patients with lung cancer who receive antitumor therapy have low immunity,and the risk of severe illness and death once infected is much higher than healthy people,so they are vulnerable to COVID-19 infection.At present,less attention has been paid to the prevention and treatment of COVID-19 infection in patients with lung cancer in domestic guidelines and consensus.Based on the published data in China and abroad,we proposed recommendations and formed expert consensus on the vaccination of COVID-19,the use of neutralizing antibodies and small molecule antiviral drugs for patients with lung cancer,for physician's reference.

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.

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.

OBJECTIVE To further standardize the implementation and management standards of pharmaceutical active consultation in medical institutions and provide a reference for providing high-quality pharmaceutical services. METHODS Guided by the Chongqing Pharmaceutical Association and led by the Third Affiliated Hospital of Chongqing Medical University， a panel of experts consisting of pharmaceutical and medical management professionals from multiple medical institutions was established to discuss the basic requirements， service processes， quality control， and evaluation improvement of pharmaceutical active consultation. The drafting team then organized， summarized， analyzed and revised the opinions， and provided feedback to ultimately form a consensus. RESULTS & CONCLUSIONS This consensus provides a detailed exposition of the basic requirements， service processes， quality control， and evaluation improvement of pharmaceutical active consultation， offering standards for the implementation of pharmaceutical active consultation in medical institutions in China， which is of major implications for strengthening the pharmaceutical service capabilities of medical institutions.

Cancer-related hypertension(CR-HTN)is a common and significant clinical issue in cancer patients,leading to poor prognosis.However,there is still a lack of unified understanding and standardized management for this condition.The Society of Integrative Cardio-On-cology,China Anti-Cancer Association,has developed this consensus based on clinical research evidence and practical experience.It provides a detailed overview of the epidemiology,pathogenesis,diagnosis and differential diagnosis,treatment,prognosis,and follow-up of CR-HTN.The consensus advocates for a proactive blood pressure monitoring strategy to detect CR-HTN early and recommends an integrated ap-proach combining anti-hypertensive and anti-cancer therapies to standardize the management of CR-HTN,thereby improving the diagnosis and treatment levels of CR-HTN in China.

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.