Electronic Common Technical Document Implementation in Japan
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Kiyohito Nakai, PhD Deputy Director, Compliance and Narcotics Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health. Labor and Welfare; Former Priority Review Director, PMDA Yasrhiro Aroki Reviewer. Office of New Drug 1K PMDA Daigoro Ebina, MS IT Expert, PMDA loku Watanabe 1T Expert. PMDA Yumi lanaka, MS Reviewer, Office of Review Management, PMDA
Satorhi Toyorhima, PhD Executive Director. PMDA
Key Words eCTD; Review; PMDA; Clinical trial; Electronic standardization Correspondence Address Kiyohito Nakai, PhD. Deputy Director, Compliance and Narcotics Division. Pharmaceutical and Medical Safety Bureau. Ministry of Health, Labor and Welfare. 1-2-2.Kasumigaseki. Chiyoda-ku. Tokyo 1008916 japan (email: [email protected]). The views expressed in this article are the authors' opinions and d o not necessarily represent the views orfindings ofthe Pharmaceuticals and Medical Devices Administration and Ministry ofHealth. Labor and Welfare.
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Electronic Common Technical Document Implementation in Japan The main missions of the Phaimaceuticals and Medid Devices Agency (PMDA) me the review of drug applications and also being in charge of the dectnmic common technical document (eC7D) regulat'ons in the m*ewpmcess. Hawever; we believe that we should consider enhancing ecI1)impZementatiosr with other activities in decbwric s* 'on of dinid trials. With this sense, the Ministry of H d t h , Labor and Wdfme (MHLw) and PMDA are coopemtingto enhance eCTD and e-dinical trials in Jqpmr.
INTRODUCTION The main missions of the Pharmaceuticals and Medical Devices Agency (PMDA) are the review of drug applications and also being in charge of electronic common technical document (eCTD) regulations in the review process. However, we should consider enhancing eCTD implementation with other activities in electronic standardization of clinical trials. With this sense, the Ministry of Health, Labor and Welfare (MHLW) and PMDA are cooperating with PMDA to enhance eCTD and e-clinical trials in Japan. In this article, we would like to introduce eCTD implementation in Japan, and also our concept for enhancing eCTD submission in view of the Japanese government initiative for supporting the development of new drugs by the electronic standardization of clinical trials.
eCTD REVIEW PROCESS I N P M D A PMDA has a very broad role in the life cycle of pharmaceuticals and medical devices (Figure 1) (1-6). In the R&D phase, PMDA provides consultations for both nonclinical and clinical studies. After the company submits the application for approval, PMDA reviews the application and conducts the good laboratory practice, good clinical practice (GCP), and good manufacturing practice inspections, and makes a re-
This article introduces eCTD implementation in Japan, and also our concept for enhancing eCTD submissions in view of the Japanese government initiative for supporting the development of new drugs by the electronic standardization of clinical trials. PMDA is keen to have eCTD submissions and hopes these activitiesfor eCTD wil
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