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各国との協力関係の強化

 厚生労働省/PMDAは、日本国民の健康と安全の向上、ひいては世界の保健衛生の向上のために、世界各国の規制当局等と協働しています。

世界の規制当局等と厚生労働省/PMDAとの関わり

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世界の規制当局とPMDAとの関わり

守秘取り決め(Confidential Arrangements)

  1. 海外規制当局
Partner Type of Arrangement Documentation Date of Signature
Nation (Region) Organization from JAPAN to JAPAN
AUSTRALIA TGA Confidentiality Arrangement PDF PDF 6 Sep. 2011
BRAZIL ANVISA Confidentiality Arrangement PDF PDF 26 Nov. 2012
CANADA Health Canada Confidentiality Arrangement PDF PDF 9 Oct. 2009
EU EC Confidentiality Arrangement
(医療機器、extended)
PDF PDF 6 Jul. 2015*1
EC Confidentiality Arrangement
(化粧品)
PDF PDF 6 Jul. 2015*1
EC/EMA Confidentiality Arrangement (extended) PDF PDF 2 Feb. 2013
EC/EMA (expired)
Confidentiality Arrangement (extended)
PDF PDF 2 Feb. 2012
EC (expired)
Confidentiality Arrangement
(医療機器)
PDF PDF 28 Oct. 2009*2
EC/EMEA (expired)
Confidentiality Arrangement
PDF PDF 2 Feb. 2007
FRANCE ANSM Confidentiality Arrangement PDF PDF 28 Nov. 2012
IRELAND IMB
(currently HPRA)
Confidentiality Arrangement PDF PDF 23 Oct. 2011
ITALY AIFA Confidentiality Arrangement PDF PDF 26 Nov. 2012
SINGAPORE HSA Memorandum on Information Exchange PDF PDF 13 May 2010
SWITZERLAND Swissmedic Confidentiality Arrangement PDF PDF 7 Nov. 2010*3
THE NETHERLANDS MEB Confidentiality Arrangement PDF PDF 20 Nov 2014
UK MHRA Confidentiality Arrangement PDF PDF 14 Oct.2010
USA FDA Confidentiality Commitment Statement PDF PDF 15 Sep. 2004*4

 

*1 Signed by EC on 14 Jul. 2015
*2 Signed by EC on 19 Oct. 2009
*3 Signed by Swissmedic on 3 Nov. 2010
*4 Signed by MHLW on
Signed by PMDA on
23 Jul. 2004
29 Jul. 2004

 

  1. 国際機関
Partner
Organization
Type of Arrangement Documentation Date of Signature
from JAPAN to JAPAN
EDQM of
the Council of Europe
Confidentiality Arrangement PDF PDF 13 Sep. 2016
WHO Confidentiality Arrangement PDF PDF 7 Oct. 2016*1

 

*1 Signed by PMDA on 13 Oct. 2016

協力覚え書(Memorandum of Understanding/Memorandum of Cooperation)

  1. 海外規制当局
Partner Type of Arrangement Documentation Date of Signature
Nation (Region) Organization
Brazil ANVISA Memorandum of Cooperation Japanese Sep. 2015
English
India CDSCO Memorandum of Cooperation Japanese Dec. 2015
English
Korea MFDS Memorandum of Cooperation Japanese Aug. 2015
English
P.R.CHINA SFDA
(currently CFDA)
Memorandum of Understanding Japanese/Chinese Jan. 2009
English translation

 

  1. 国際機関
Partner
Organization
Type of Arrangement Documentation
Date of Signature
EDQM of
the Council of Europe
Memorandum of Cooperation Japanese Sep. 2016
English
ChP Memorandum of Cooperation Japanese/Chinese Sep. 2016
English
USP Memorandum of Cooperation Japanese Sep. 2016
English



 
Official Names:
EU: European Union
P.R.CHINA: The People's Republic of China
UK: the United Kingdom of Great Britain and Northern Ireland
USA: the United States of America
   
AIFA : Agenzia Italiana del Farmco
The Italian Medicines Agency
ANSM : L'Agence Nationale de Sécurité du Médicament et des produits de santé
The French National Agency for Medicines and Health Products Safety
ANVISA : Agência Nacional de Vigilância Sanitária
The Brazilian Health Surveillance Agency
CDSCO : Central Drugs Standard Control Organization
CFDA : China Food and Drug Administration
ChP: Chinese Pharmacopoeia Commission
EC : European Commission
EDQM: European Directorate for the Quality of Medicines & HealthCare
EMA (Former EMEA) : European Medicines Agency
FDA : Food and Drug Administration
HPRA : Health Products Regulatory Authority
HSA : Health Sciences Authority
IMB : The Irish Medicines Board
MFDS : Ministry of Food and Drug Safety
MHRA : Medicines and Healthcare products Regulatory Agency
MEB : Medicines Evaluation Board
NPCB : National Pharmaceutical Control Bureau
SFDA : State Food and Drug Administration
TGA : Therapeutic Goods Administration
USP: United States Pharmacopeial convention
WHO: World Health Organization
   
MHLW : Ministry of Health, Labour and Welfare
PMDA : Pharmaceuticals and Medical Devices Agency
 

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