In June 2021, the Ministry of Health, Labor and Welfare approved Delytact Injection as a regenerative medical product for oncolytic virus therapy. The active substance of Delytact Injection is teserpaturev, a genetically engineered herpes simplex virus type 1 (strain F) in which the α47 gene and both copies of the γ34.5 gene have been deleted and the infected cell protein 6 (ICP6) gene has been inactivated by the insertion of the lacZ gene from Escherichia coli. Delytact Injection, when intratumorally administered to patients with malignant glioma, is expected to exert the following effects: (1) the mutant virus selectively replicates in tumor cells and destroys the infected cells through the replication process, exerting a cytocidal effect, and (2) the administration leads to induction of tumor-responsive T cells, which activates antitumor immunity and thus prolongs the survival of patients with malignant glioma. A Japanese phase II study (Study GD01) was conducted in patients with glioblastoma who had residual or recurrent tumors after radiotherapy with concomitant temozolomide. In Study GD01, however, stable disease continued for an extended period in some patients with glioblastoma. Hence, Delytact Injection is expected to be effective to a certain level. In line with this, Delytact Injection has been approved as an option for the treatment of malignant glioma, with one of the 3 approval conditions including conducting a use-results comparison survey and resubmission of the marketing authorization application within the granted time period of 7 years, under the conditional and time-limited approval scheme described in Article 23–26 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
The Pharmaceuticals and Medical Devices Agency, PMDA, plays three key roles, namely relief services for persons injured by adverse reactions to drugs and regenerative medical products, product reviews, and safety measures. Based on the concept of the regulatory science, PMDA has been conducting evidence-based review and evaluation, and has been providing citizens and healthcare professionals with rapid access to safer, more effective medical products.To promote innovative products, PMDA took various measures, i.e. establishment of expedited review tracks and consultation services in response to the needs. Also, the efforts and challenges we face to combat COVID-19 would be introduced in this session. Today, international collaboration and convergence is necessary and essential in the field of regulatory affairs. PMDA has been continuously contributing to the ICMRA, International Coalition of Medicines Regulatory Authorities, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities. The COVID-19 related issues are hot topics of the ICMRA discussion. The latest international trends of the regulatory affairs, and current situation and challenges of the development of the products would be introduced in this session. 独立行政法人医薬品医療機器総合機構(PMDA)は、健康被害救済業務、承認審査業務及び安全対策業務の3つの 業務を柱とした機関である。 平成16年に発足以来、レギュラトリーサイエンスの考え方に基づく適正な承認審査や安全対策の評価を行い、より 安全で有効な医薬品・医療機器等をいち早く国民に届けられるよう様々な対策・組織強化を図ってきた。例えば、 医療イノベーション推進に向けた迅速な承認審査制度や相談制度の構築、レギュラトリーサイエンスセンターの設 置、さらに世界的に猛威を振るっている新型コロナウイルス感染症に関する取り組みについて紹介する。 さらに、薬事規制は国内に留まらず世界との調和・協力が欠かせない時代となっている。PMDAは薬事規制当局の 長官レベルの国際会合であるICMRA(International Coalition of Medicines Regulatory Authorities)に参画し、新型 コロナウイルス感染症関連製品を含め、薬事規制の国際的なコンセンサスの構築に貢献している。 今般の薬事規制の国際動向や製品開発の現状と課題について紹介する。
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.