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Bilateral Cooperation

Bilateral Cooperation between MHLW/PMDA and Foreign Regulatory Authorities

Bilateral Cooperation between PMDA and Foreign Regulatory Authorities

Confidential Arrangements

  1. Regulatory Authorities
Confidentiality Arrangements
Partner Type of Arrangement Documentation Date of Signature
Nation (Region) Organization from JAPAN*1 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
(Medical Device, extended)
PDF PDF 6 Jul. 2015*1
EC Confidentiality Arrangement
(Cosmetics)
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
(Medical Device)
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. International Organizations
  Partner
Organization
Type of Arrangement Documentation Date of Signature
from
JAPAN
to
JAPAN
EDQM of
the Council
of Europe
Confinentiality Arrangement PDF PDF 13 Sep. 2016
WHO Confinentiality Arrangement PDF PDF 7 Oct. 2016*1
 
*1 Signed by PMDA on 13 Oct. 2016

Memorandum of Understanding/Memorandum of Cooperation

  1. Regulatory Authorities
Cooperative Arrangements
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. International Organizations
Partner
Organizations
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
Memoraudum of
Cooperation
Japanese Sep. 2016
English
 

Acronyms

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
MEB : Medicines Evaluation Board
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

China/Japan/Korea Tripartite Cooperation

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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Bilateral Cooperation
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