The worldwide pandemic of COVID-19 brought a significant impact in Japan. Pfizer Japan Inc. received exceptional approval of COMIRNATY in February 2021. Temporary vaccination was initiated 3 days later. Pharmacovigilance at the start of sales is particularly important because the use experience is limited under the circumstances of exceptional approval. Therefore, we considered it essential to collect and analyze the safety information certainly and rapidly, and to provide the information in securing the safety of users and promoting the temporary vaccination project. Prior to the use of COMIRNATY, we estimated the number of adverse event (AE) reports based on anticipated amount of the product supply as well as the prediction from a scientific article on the AE reporting rate in the latest H1N1 influenza pandemic, and then we started to build a system including resources in the Safety Unit. However, partly owing to promotion of the vaccination, the actual number of AE reports received was the one we had never experienced. Pfizer prioritized processing of serious cases and secured resources in the Safety Unit based on vaccination status and number of AE reports. For Early post-marketing phase vigilance (EPPV), Pfizer Japan Inc. used information on vaccine delivery available on the Vaccination System (V-SYS) and conducted the provision and collection of information by leveraging digital technology. In this article, we report our experience of pharmacovigilance conducted as a marketing authorization holder of COMIRNATY under the COVID-19 pandemic, and touch upon matters that require improvement, should a pandemic occur in the future.

The OECD GLP (Good Laboratory Practice) Advisory Document No. 17 Supplement 1 (OECD GLP Guidance) published in June 2023 clarified the requirements of the GLP principles for using cloud systems. When using cloud systems, the GLP facility assesses the risks to data integrity, data quality, data availability, data retention, and data archiving and is ultimately accountable for compliance with GLP. A lot of GLP facilities in Japan handle paper records, so there are currently not many GLP facilities that use cloud systems. However, considering the issue of material storage space and the fact that LIMS data archiving is becoming cloud-based, it can be inferred that the use of cloud systems to manage electronic data will increase. Therefore, in order to enable GLP facilities to easily introduce cloud systems that comply with GLP requirements, we established a GLP operational organization structure and risk assessment perspective between sponsors and system suppliers to ensure data integrity of GLP electronic data using SaaS systems. We will introduce the results of our study.We hope that it will contribute to ensuring the reliability of electronic data management and improving productivity at GLP facilities in Japan and help in the early launch of pharmaceuticals.

The Japan Pharmaceutical Manufacturers Association’s (JPMA) 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 EU¹⁾ . 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 Established Conditions and systems of regulatory actions for changes in Japan, US and EU.

Decentralized clinical trial (DCT) is expected to have various added values, such as ensuring patient’s easy access to clinical trials regardless of their circumstances, in addition to efficient conduction of clinical trials. With the significant advancement of information and communication technology, DCT is being introduced worldwide in development of new therapeutics. In order to strengthen Japan’s drug discovery capabilities and to promote the introduction of therapeutics with highly medical needs, it is necessary to develop a domestic clinical trial environment, through incorporating new technologies such as DCT. This article outlines the recent updates of pharmaceutical regulations surrounding DCT in Japan, focusing on the guidance for online informed consent (e-consent) issued by the Ministry of Health, Labor and Welfare in March 2023, as part of efforts to promote DCT. The guidance indicates the points to be considered for e-consent, including identity verification methods, privacy protection of subjects, communication methods, use of videos, electronic signatures, etc.

This paper focused on the upcoming progression and challenges associated with Decentralized Clinical Trials (DCT) in Japan. It presents a comprehensive analysis of both the international and domestic states of DCTs, and offers strategic recommendations for their promotion and development within Japan’s clinical trial framework. The discussion includes patient-centric strategies, the importance of data integration, and expanding opportunities for subject participation. An examination of how DCTs can streamline clinical trials and enhance patient healthcare is also provided, indicating a significant role for DCTs in improving the clinical trial ecosystem in Japan.

Under the concept of Patient Centricity, efforts to incorporate various methods of DCT in clinical trials are beginning recently. In this paper, we would like to present the background and history of DCT overseas, DCT in the United States, and actual examples of DCT initiatives by our company (Eli Lilly Japan, K. K.) in Japan from the perspective of a pharmaceutical company. Comparing the U. S. and Japan, it is obvious that the environment, laws and regulations, and cultures surrounding clinical trials are different. Even if the concept of DCT is common around the world, it is so challenging to utilize all methods of DCT are common to the whole world. Therefore, when promoting DCT in Japan, it is necessary to distinguish between the parts that are promoted globally and the parts that are promoted with a strong awareness of the uniqueness of Japan (the method of introduction in accordance with the environment of Japan) with the spirit of “Think Globally, Act Locally”. In addition, a “flexible regulatory environment” is one of the most important factors in advancing “Act Locally” in Japan. It is strongly awaited that the Ministry of Health, Labor and Welfare (MHLW) will issue various guidance on DCT, which are still under consideration, and that the development of related laws and regulations will progress. It is also important that the implementation of GCP E6 R3 in Japan will not hinder various innovations such as DCT. To establish the DCT implementation system, infrastructure and guidance by regulatory agencies are important. We also would like to emphasize that the importance of continuing “Co-creation”, “challenges” and “shared learning” with all stakeholders (health care providers in clinical sites, regulatory authorities, service providers, pharmaceutical companies, etc.) working together.

ICH S1 (R1) Expert Working Group (EWG) has been investigating whether the value of the conduct of a two-year rat carcinogenicity study can be judged by an integrated “weight of evidence” approach based on various factors. From the results of the prospective evaluation conducted to verify this possibility, it was possible to judge whether or not to add value to the assessment of carcinogenicity risk in humans for some groups of pharmaceutical products without conducting a 2-year rat carcinogenicity study. Therefore, it was judged appropriate to expand the new carcinogenicity assessment framework based on the integrated “weight of evidence” WoE approach, and ICH S1B (R1) guideline was finalized in August 2022 and implemented in March 2023 in Japan. This review describes an overview of the background to the revision of the guideline and the prospective evaluation on which the revision was based.