Pharmacists contribute to improving the safety of pharmacotherapy and the efficiency of healthcare financing through prescription inquiries. This study aimed to examine the challenges to future pharmacist services by analysing the relationship between the characteristics of pharmacies/pharmacists and the number of prescription inquiries. The survey was conducted in cooperation with the Japan Pharmaceutical Association and the Nippon Pharmacy Association. Individual members of each organisation were asked to respond to an online survey form. The participants were allowed to choose any one-month period between December 2018 and March 2019 to answer the online questionnaire. Valid survey responses were obtained from 2,117 pharmacies (76％) and 5,024 pharmacists (88％). The results of this study showed that the number of prescription inquiries was significantly higher in the “71-85,” “86-94,” and “95％ or more” groups compared to the “70％ or less” prescription concentration rate group. In terms of pharmacist information, the number of prescription inquiries was significantly higher in the “Understanding the prescribing intentions of collaborating physicians and the disease background of the patient” group and the “Daily collaboration with physicians of the main responding medical institution” group. Furthermore, the number of prescription inquiries was significantly higher in the “Not enough time for medication guidance” group and the “Dissatisfied with pharmacists’ work” group. This study indicated that the relationship between pharmacies/pharmacists and medical institutions/physicians affects the number of prescription inquiries. It was also suggested that a certain number of pharmacists find prescription inquiries burdensome, and that improving the efficiency of pharmacist work is an issue to be addressed in the future.

 The aim of this study is to examine the status quo of Community Collaborative Pharmacy (CCP) and Specialized Medical Institution Cooperating Pharmacy (SMICP) certification utilizing the pharmacy function information from pharmacies in Chiba Prefecture, leading to the identification of the current challenges of CCP certification for uncertified pharmacies. This study included 96 pharmacies (2021), 146 pharmacies (2022) as CCPs and 4 pharmacies (2021), 6 pharmacies (2022) as SMICPs. As uncertified pharmacies, all 2,497 in 2019 and 2,430 pharmacies in 2022 (excluding CCP and SMICP) were included. While 83.6％ of CCPs shared information with medical institutions at other times unrelated to admission or discharge, the rates at admission and discharge were only 27.4％ and 25.3％, respectively (2022). 56.2％ of CCPs have the necessary infrastructure for sterile dispensing, but only 11.6％ dispensed sterile drugs (2022). Among uncertified pharmacies, the lowest achievement rate was observed for having the necessary infrastructure for dispensing sterile products, being only 6.4％ (2019) and 7.7％ (2022). Binomial logistic regression analysis was used to determine factors related to CCP certification. Implementation of sharing information about medication adherence with medical institutions (p＝0.008), having the necessary infrastructure for dispensing sterile products (p＜0.001), and 3 other items showed statistically significant differences between uncertified pharmacies and CCPs (p＜0.05). To improve information sharing, it is necessary to collaborate closely with medical institutions with an inpatient department. Considering sterile dispensing, it is essential for pharmacies to have the necessary infrastructure and to inform patients and other medical professionals that they possess such functions.

 This study investigates the current utilization of clinical research data in regulatory applications for medical devices and analyzes trends in products that were utilized clinical trial data. The goal is to provide insights into the potential for using clinical research data as an alternative for products that currently require clinical trials and to discuss the direction of their use. The research focused on products approved between April 2013 and March 2023 that conducted clinical evaluation for approval. Products listed on the PMDA website that utilized clinical data for regulatory applications, the number of products approved based on clinical research in Japan tended to be few. Products approved through clinical trials tend to be either high-risk with relative novelty or improved medical devices not novel in treatment but considered for trials due to changes in raw materials or similar modifications with relatively minor clinical added value, indicating no prior human use. For the latter, clinical research data conducted with sufficient consideration for reliability assurance may be an alternative to confirm efficacy and safety. The study suggests that by Ministry of Health, Labour and Welfare presenting examples of utilization according to each type of clinical evidence (clinical trials, clinical research, literature, etc.), it could facilitate the use of clinical research data in regulatory applications.

 When using medical devices in clinical practice, there are limits to the ability to ensure the safety of patients and users with the safety risk information obtained before marketing, subject to conditions regarding target patients and usage conditions. Malfunction reporting systems allow post-marketing malfunctions of medical devices or health effects on patients from approved medical devices to be reported to regulatory authorities. Such systems are established by law not only in Japan, but also in other countries and require marketing authorization holders to report to regulatory authorities according to certain criteria. Compared with overseas systems, reporting criteria for malfunction reports were found to be fragmented in Japan.

 The Japan Pharmaceutical Manufacturers Association’s Regulatory Affairs Committee conducted the first survey about the actual situation of quality related Established Conditions, the submission category for changes, review periods and GMP inspection in Japan, US and EU in 2022 and reported differences in Japan, US and EU. We conducted the second survey to seek the cause of the differences in Japan, US and EU based on the result of the first survey and report differences in GMP inspection in Japan, US and EU.

 The supply shortage of medical drugs, which has expanded since 2021, has not been resolved even after three years, and in addition to the problems of manufacturing and quality management deficiencies and corporate governance that triggered the issue, the impact of drug distribution, industrial structure, inflation, and supply chain challenges has also been pointed out, and the background and causes are becoming more complex. The Ministry of Health, Labour and Welfare (MHLW) is taking measures to address current supply uncertainties by requesting increased production from pharmaceutical manufacturers and collecting and disclosing information related to supply conditions. Additionally, considering the structural issues in the generic drug industry that contribute to supply concerns, MHLW aims to encourage industry efforts while highlighting the desired state of the sector.

 Currently, the Federation of Pharmaceutical Manufacturers’ Associations of JAPAN has set up subcommittees and projects within the Stability Ensuring Committee, which acts as a contact point for various review meetings sponsored by the Ministry of Health, Labor and Welfare. Factors contributing to the unrest in the supply of pharmaceuticals include: (1) drug substance (global products, geopolitical risks, pandemics, emergencies), (2) Information (individual, overall, system, disclosure, analysis), (3) Quality (compliance) issues, and (4) Industrial structural issues. Multiple factors are intertwined, and in order to resolve the factors, it is necessary to unravel each of the intertwined factors one by one. As an industry organization, we will continue to work towards achieving a stable supply of pharmaceuticals with the aim of resolving supply concerns.

 Since 2020, non-compliance of good manufacturing practices (GMPs) and quality-related problems have induced Japan’s prolonged large-scale supply disruption of generic pharmaceuticals. This manuscript outlines the changes in the manufacturing control method and GMP regulation based on quality by design (QbD) concept in the last two decades. It also discusses the rapid increase in the use of generic products during the government-supported campaign, resulting in violations such as non-conformity in manufacturing methods and/or non-compliance with the quality standards recommended for monitoring the stability of specific products. Insufficient verification of commercial-level production in the product development process by some marketing authorization holders was cited as a significant cause of the intensive occurrence and prolongation of the problem. It is essential to design processes emphasizing the product life cycle and to build systems allowing for rational changes to ensure a stable and ethical supply of pharmaceuticals.

 Pharmaceuticals and Medical Devices Agency of Japan (PMDA) has been working with the Ministry of Health, Labour and Welfare (MHLW) and prefectural governments to ensure manufacturing and quality control systems, which is the foundation for a stable supply of quality-assured pharmaceutical products, through GMP inspection and other measures. Recently, PMDA has begun a new initiative to promote risk communication related to pharmaceuticals quality, such as facilitating dialogue between industry side and regulatory side and promoting visualization of pharmaceuticals quality, with the aim of further improving manufacturing and quality control at pharmaceuticals manufacturing facilities. We introduce these initiatives included in the 5th Mid-Term Plan of PMDA, which start in 2024 and their future prospects.

 Discussions with industry and academic experts at the meeting held by the Ministry of Health, Labor and Welfare in 2023 led to a notification entitled “Basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan.” The notification was issued as a measure against drug lag/drug loss, and existing notifications were revised. Many people attach importance to the new notification stating that “In principle, an additional phase 1 study in Japanese is not needed unless it is deemed necessary after assessing whether the safety/tolerability of the dosage to be evaluated in the multi-regional clinical trials in Japanese participants can be explained and the safety is clinically acceptable/manageable based on the data available prior to Japan’s participation.” In this article, I would like to communicate the backgrounds behind the re-issuance of the notification regarding “Phase I studies in Japanese patients prior to participation in multi-regional clinical trials.”