RESEARCH PAPER
September 28, 2007
Notification No.0928010
Attention to:
Commissioner of Prefectural Health Supervising Department
From Director of Evaluation and Licensing Division,
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare
Basic principles on Global Clinical Trials*
Up to the present according to “Ethnic Factors in the Acceptability of Foreign Clinical Data” based on ICH-E5 guideline (Notification. No. 762, Director of Evaluation and Licensing Division,
Pharmaceutical and Food Safety Bureau, Ministry of Health and Welfare, dated August 11, 1998), utilizing foreign clinical trial data in a new drug application what is called “Bridging” has been accepted in Japan, and post-marketing data in USA and EU have been taken into consideration in a review for regulatory approval where necessary.
On the other hand, in the report entitled “Institutional reform for promoting science and technology and passing on the benefits of the scientific and technological advance” (Council for
Science and Technology Policy, dated December 2006), it is mentioned to encourage global clinical trials in terms of efficient and rapid developments of new drugs. Moreover, in the final report of the special committee for “Effective & Safe Drugs Quick to Patients” (dated July, 2007), it is pointed out to promote global clinical trials in order to resolve “Drug lag (Circumstances where drug approved in EU and US are not approved in Japan and can not be provided to nations)” and to clear points to consider for conducting global clinical trials from the perspective of a review for regulatory approval. Taking into account the situation, current understanding regarding global clinical trials based on experiences in PMDA consultations is outlined as the attachment, entitled “Basic principles on global clinical trials”. We ask to inform manufacturers and sellers placed under your administration to utilize this for their business operations.
In addition,
Notification No.0928010
Attention to:
Commissioner of Prefectural Health Supervising Department
From Director of Evaluation and Licensing Division,
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare
Basic principles on Global Clinical Trials*
Up to the present according to “Ethnic Factors in the Acceptability of Foreign Clinical Data” based on ICH-E5 guideline (Notification. No. 762, Director of Evaluation and Licensing Division,
Pharmaceutical and Food Safety Bureau, Ministry of Health and Welfare, dated August 11, 1998), utilizing foreign clinical trial data in a new drug application what is called “Bridging” has been accepted in Japan, and post-marketing data in USA and EU have been taken into consideration in a review for regulatory approval where necessary.
On the other hand, in the report entitled “Institutional reform for promoting science and technology and passing on the benefits of the scientific and technological advance” (Council for
Science and Technology Policy, dated December 2006), it is mentioned to encourage global clinical trials in terms of efficient and rapid developments of new drugs. Moreover, in the final report of the special committee for “Effective & Safe Drugs Quick to Patients” (dated July, 2007), it is pointed out to promote global clinical trials in order to resolve “Drug lag (Circumstances where drug approved in EU and US are not approved in Japan and can not be provided to nations)” and to clear points to consider for conducting global clinical trials from the perspective of a review for regulatory approval. Taking into account the situation, current understanding regarding global clinical trials based on experiences in PMDA consultations is outlined as the attachment, entitled “Basic principles on global clinical trials”. We ask to inform manufacturers and sellers placed under your administration to utilize this for their business operations.
In addition,