Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval

Abstract Under the International Council for Harmonization (ICH)‐E1 guideline for drugs intended for chronic or repeated intermittent use in non‐life‐threatening diseases, data from 100 patients exposed for a minimum of 1 year are required to be included in the safety data base of a new drug applica...

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Autores principales:	Shinobu Uzu, Shohko Sekine, Junichi Asano, Mutsuhiro Ikuma
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/4f110dba9e164384af91d02ec52ee583
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spelling	oai:doaj.org-article:4f110dba9e164384af91d02ec52ee5832021-11-19T17:51:35ZAssessment of the impact of Japanese‐specific long‐term safety data on new drug approval1752-80621752-805410.1111/cts.13098https://doaj.org/article/4f110dba9e164384af91d02ec52ee5832021-11-01T00:00:00Zhttps://doi.org/10.1111/cts.13098https://doaj.org/toc/1752-8054https://doaj.org/toc/1752-8062Abstract Under the International Council for Harmonization (ICH)‐E1 guideline for drugs intended for chronic or repeated intermittent use in non‐life‐threatening diseases, data from 100 patients exposed for a minimum of 1 year are required to be included in the safety data base of a new drug application. In response to the recent globalization of drug development, the Ministry of Health, Labour, and Welfare of Japan requires that the data according to the ICH‐E1 guideline should be collected from 100 Japanese patients by the administrative notice of Basic Principles on Global Clinical Trials (reference cases) by considering ethnic differences in safety between Japanese and foreigners. In this study, we assessed Pharmaceuticals and Medical Devices Agency (PMDA) review reports of new drugs from 2016 to 2020 that include safety data for 100 Japanese patients exposed to these drugs for a minimum of 1 year to see if the study data led to the detection of Japanese‐specific safety issues. The result showed that the safety data from these patients provided only marginal value to identify Japanese‐specific safety issues, and no drugs were subjected to regulatory measures. Based on these studies and the fact that Japanese‐specific safety differences detected for a few drugs did not lead to adaptations of drug regulatory measures, we would like to propose not to make it a rule to collect safety data from 100 Japanese patients exposed at least 1 year, while keeping the ICH‐E1 guideline.Shinobu UzuShohko SekineJunichi AsanoMutsuhiro IkumaWileyarticleTherapeutics. PharmacologyRM1-950Public aspects of medicineRA1-1270ENClinical and Translational Science, Vol 14, Iss 6, Pp 2339-2347 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270
spellingShingle	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270 Shinobu Uzu Shohko Sekine Junichi Asano Mutsuhiro Ikuma Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval
description	Abstract Under the International Council for Harmonization (ICH)‐E1 guideline for drugs intended for chronic or repeated intermittent use in non‐life‐threatening diseases, data from 100 patients exposed for a minimum of 1 year are required to be included in the safety data base of a new drug application. In response to the recent globalization of drug development, the Ministry of Health, Labour, and Welfare of Japan requires that the data according to the ICH‐E1 guideline should be collected from 100 Japanese patients by the administrative notice of Basic Principles on Global Clinical Trials (reference cases) by considering ethnic differences in safety between Japanese and foreigners. In this study, we assessed Pharmaceuticals and Medical Devices Agency (PMDA) review reports of new drugs from 2016 to 2020 that include safety data for 100 Japanese patients exposed to these drugs for a minimum of 1 year to see if the study data led to the detection of Japanese‐specific safety issues. The result showed that the safety data from these patients provided only marginal value to identify Japanese‐specific safety issues, and no drugs were subjected to regulatory measures. Based on these studies and the fact that Japanese‐specific safety differences detected for a few drugs did not lead to adaptations of drug regulatory measures, we would like to propose not to make it a rule to collect safety data from 100 Japanese patients exposed at least 1 year, while keeping the ICH‐E1 guideline.
format	article
author	Shinobu Uzu Shohko Sekine Junichi Asano Mutsuhiro Ikuma
author_facet	Shinobu Uzu Shohko Sekine Junichi Asano Mutsuhiro Ikuma
author_sort	Shinobu Uzu
title	Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval
title_short	Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval
title_full	Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval
title_fullStr	Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval
title_full_unstemmed	Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval
title_sort	assessment of the impact of japanese‐specific long‐term safety data on new drug approval
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/4f110dba9e164384af91d02ec52ee583
work_keys_str_mv	AT shinobuuzu assessmentoftheimpactofjapanesespecificlongtermsafetydataonnewdrugapproval AT shohkosekine assessmentoftheimpactofjapanesespecificlongtermsafetydataonnewdrugapproval AT junichiasano assessmentoftheimpactofjapanesespecificlongtermsafetydataonnewdrugapproval AT mutsuhiroikuma assessmentoftheimpactofjapanesespecificlongtermsafetydataonnewdrugapproval
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Assessment of the impact of Japanese‐specific long‐term safety data on new drug approval

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