Issues with infectious disease vaccine introduction into routine vaccination in Japan, and considerations for accelerating the process.

Routine vaccinations help prevent the outbreak and spread of infectious diseases; however, it can take up to ten years from vaccine approval to introduction into routine vaccination schedules in Japan. Here, we investigate the information required to introduce an approved vaccine into routine vaccination schedules and the reasons why it takes so long. Based on the published data of the Immunization and Vaccine Committee of the Health Science Council, we set out to explore ways to facilitate discussion on this topic.

Incidence of interstitial lung disease in patients with breast cancer: a nationwide database study in Japan.

This study estimated the incidence of moderate-to-severe drug-induced interstitial lung disease (ILD) among patients with breast cancer in Japan. We analyzed a large nationwide database of patients with breast cancer treated with anticancer therapies between 2009 and 2022. ILD was identified using diagnostic codes and treatment records.

Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in Japan.

In the past few years, there have been several instances of illicit pharmaceutical manufacturing in Japan, and there is a growing awareness of the importance of corporate compliance and pharmaceutical manufacturing and quality controls. One cause of illicit manufacturing is the inadequate development of quality culture. This study focuses on the degree of quality culture development in Japanese pharmaceutical companies manufacturing generic drugs.

Implementation status and consideration for the globalisation of decentralised clinical trials: a cross-sectional analysis of clinical trial databases.

Objective: To comprehensively elucidate the current landscape of decentralised clinical trials (DCTs) and identify notable aspects that can facilitate DCT implementation.

Design: Cross-sectional analysis.

Setting: Data were extracted using selected DCT-specific search terms on 4 June 2022, from the ClinicalTrials.

Quality Culture and Knowledge Management in the Japanese Pharmaceutical Industry-A Cross-Sectional Study and Case Report.

In the past few years, there have been several instances of illicit pharmaceutical manufacturing in Japan. Insufficient good manufacturing practice compliance and lack of quality culture in some pharmaceutical companies have been suggested as the underlying reasons for such cases. We aimed to focus on knowledge management and fostering of quality culture in pharmaceutical companies in Japan to understand their current situation and find a strategy for the availability of high-quality reliable pharmaceutical products.

Addressing practical issues in the smooth implementation of revised guidelines for non-clinical studies of vaccines for infectious disease prevention.

Herein, we investigated possible practical issues for the smooth implementation of the revised Japanese Guidelines for Non-clinical Studies of Vaccines for the Prevention of Infectious Diseases, which were raised in response to public comments on the proposed guideline revision and a gap analysis of the World Health Organization and European Medicines Agency guidelines. We identified main issues such as the non-clinical safety studies of adjuvants and evaluation of local cumulative tolerance in toxicity studies. The revised Japanese Pharmaceuticals and Medical Devices Agency (PMDA)/Ministry of Health, Labour and Welfare (MHLW) guidelines require non-clinical safety studies for vaccines containing new adjuvants, but additional safety pharmacology studies or safety studies in two animal species may be required if non-clinical safety studies raise any concerns (i.

Horizon Scanning in Tissue Engineering Using Citation Network Analysis.

Background: Establishing a horizon scanning method is critical for identifying technologies that require new guidelines or regulations. We studied the application of bibliographic citation network analysis to horizon scanning.

Objective: The possibility of applying the proposed method to interdisciplinary fields was investigated with the emphasis on tissue engineering and its example, three-dimensional bio-printing.

Points to Consider in the Development and Information Provision of Vaccines for Vaccination during Pregnancy: A Survey.

This report surveyed vaccination decisions during pregnancy based on the package inserts of vaccines approved in Japan, the USA, and Europe. Furthermore, it evaluates vaccination decision-making factors based on the characteristics of the target infections and the modality of the vaccines. Live vaccines known to cause fetal abnormalities are contraindicated for pregnant women, whereas vaccines for life-threatening infectious diseases are authorized for administration during pregnancy when the need is recognized, even for live vaccines.

Impact of the Clinical Trials Act 2018 on clinical trial activity in Japan from 2018 to 2020: a retrospective database study using new and conventional Japanese registries.

Objective: To clarify the impact of Japan's Clinical Trials Act (CTA), which was enacted in April 2018, on subsequent clinical trial activity through an analysis of Japanese registry data.

Design: Retrospective database study.

Setting: We extracted information on clinical intervention studies registered between 1 April 2018 and 30 September 2020 in the conventional University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) and the new Japan Registry of Clinical Trials (jRCT).

Application of Internet of Medical/Health Things to Decentralized Clinical Trials: Development Status and Regulatory Considerations.

Background: The need for a new style of clinical trials, called decentralized clinical trials (DCTs), has been increasing as they do not depend on physical visits to clinical sites. DCTs are expected to provide a new opportunity to patients who cannot participate in a clinical trial due to geographical and time limitations. For the adoption of DCTs, it is essential that medical devices with Internet of Medical Things (IoMT) and Internet of Health Things (IoHT) based technologies are developed and commercially adopted.

Study on Horizon Scanning with a Focus on the Development of AI-Based Medical Products: Citation Network Analysis.

Horizon scanning for innovative technologies that might be applied to medical products and requires new assessment approaches to prepare regulators, allowing earlier access to the product for patients and an improved benefit/risk ratio. The purpose of this study is to confirm that citation network analysis and text mining for bibliographic information analysis can be used for horizon scanning of the rapidly developing field of AI-based medical technologies and extract the latest research trend information from the field. We classified 119,553 publications obtained from SCI constructed with the keywords "conventional," "machine-learning," or "deep-learning" and grouped them into 36 clusters, which demonstrated the academic landscape of AI applications.

Study on Horizon Scanning by Citation Network Analysis and Text Mining: A Focus on Drug Development Related to T Cell Immune Response.

Certain innovative technologies applied to medical product development require novel evaluation approaches and/or regulations. Horizon scanning for such technologies will help regulators prepare, allowing earlier access to the product for patients and an improved benefit/risk ratio. This study investigates whether citation network analysis and text mining of scientific papers could be a tool for horizon scanning in the field of immunology, which has developed over a long period, and attempts to grasp the latest research trends.

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity.

The mission of medicines regulatory agencies is to ensure the timely access of innovative products for patients to improve public health. Thus, regulators should foresee evolving technologies and build expertise prior to reviewing innovative products. Novel modalities and new classes of therapeutics in biological or cell-based products represent a regulatory challenge because of knowledge gaps, as exemplified by the unexpected cytokine release syndrome in the first-in-human clinical trial of the CD28 super-agonist.

Mixed alkali-ion transport and storage in atomic-disordered honeycomb layered NaKNiTeO.

Honeycomb layered oxides constitute an emerging class of materials that show interesting physicochemical and electrochemical properties. However, the development of these materials is still limited. Here, we report the combined use of alkali atoms (Na and K) to produce a mixed-alkali honeycomb layered oxide material, namely, NaKNiTeO.

Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies.

The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use M9 Guidelines for Biopharmaceutics Classification System Biowaivers reached harmonization in November 2019. However, guidelines for bioequivalence studies are not internationally harmonized, and water as a dissolution medium is only required in Japanese guidelines, regardless of drug solubility. This study investigated the dissolution profiles of generic products in Japan that differ from those of original drugs in dissolution media defined in guidelines.

Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan.

Background: For pharmaceutical products, an in-depth understanding of manufacturing processes and quality risks associated with quality by design (QbD) development enables the production of high-quality products. Product recall due to quality issues could be minimized for QbD-developed products. Furthermore, the review period instituted by regulatory authorities could be shortened by allowing reviewers to access technical documents with QbD elements.

Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake Designation.

Background: In the breakthrough therapy designation (BTD) and Sakigake designation programs, rolling submission and close communication between applicants and regulatory authorities enable the timely access of patients to innovative medicines. However, challenges in the quality development, including chemistry, manufacturing, and control (CMC), are expected during the accelerated timeline. This study focused on development with quality by design (QbD) concept, shelf life of drug product, and post marketing commitment (PMC) to clarify developmental strategies and regulatory challenges associated with expedited approval programs.

New insight derived from a two-compartment cell: electrochemical behavior of FeF positive electrode.

A designed two-compartment cell was applied to the degradation analysis of FeF3 having high theoretical energy density. Comparing with the result of the coin cell, the two-compartment cell gave us insight that the elution of Fe was responsible for the degradation of FeF3 and LiDFOB was found as an essentially effective additive for suppressing the degradation of FeF3.

Analytical Measurements to Elucidate Structural Behavior of 2,5-Dimethoxy-1,4-benzoquinone During Charge and Discharge.

Organic compounds as electrode materials can contribute to sustainability because they are nontoxic and environmentally abundant. The working mechanism during charge-discharge for reported organic compounds as electrode materials is yet to be completely understood. In this study, the structural behavior of 2,5-dimethoxy-1,4-benzoquinone (DMBQ) during charge-discharge is investigated by using NMR spectroscopy, energy-dispersive X-ray spectroscopy, magnetic measurements, operando Raman spectroscopy, and operando X-ray diffraction.

Degradation Mechanism of Conversion-Type Iron Trifluoride: Toward Improvement of Cycle Performance.

Conversion-type iron trifluoride (FeF) has attracted considerable attention as a positive electrode material for lithium secondary batteries due to its high energy density and low cost. However, the conversion process through which FeF operates leads it to suffer from capacity degradation upon repeated cycling. To improve the cycle performance, in this study we investigated the degradation mechanism of conversion-type FeF electrode material.