International Arrangements

Confidential Arrangements

Confidentiality Arrangements
Partner Type of Arrangement Documentation Date of Signature
Nation (Region) Organization from JAPAN*1 to JAPAN
AUSTRALIA TGA Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
6 Sep. 2011
BRAZIL ANVISA Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
26 Nov. 2012
CANADA Health Canada Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
9 Oct. 2009
EU EC/EMA Confidentiality Arrangement (extended) PDF
(PDF)
PDF
(PDF)
2 Feb. 2013
EC/EMA Confidentiality Arrangement (extended) PDF
(PDF)
PDF
(PDF)
2 Feb. 2012
EC Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
28 Oct. 2009*2
EC/EMEA Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
2 Feb. 2007
FRANCE ANSM Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
28 Nov. 2012
IRELAND IMB Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
23 Oct. 2011
ITALY AIFA Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
26 Nov. 2012
SINGAPORE HSA Memorandum on Information Exchange PDF
(PDF)
PDF
(PDF)
13 May 2010
SWITZERLAND Swissmedic Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
7 Nov. 2010*3
UK MHRA Confidentiality Arrangement PDF
(PDF)
PDF
(PDF)
14 Oct.2010
USA FDA Confidentiality Commitment Statement PDF
(PDF)
PDF
(PDF)
15 Sep. 2004*4
 
*1  Organization of Japan Side: MHLW/PMDA (Except arrangement with USA)
PMDA (Arrangement with USA)
*2  Signed by EC on 19 Oct. 2009
*3  Signed by Swissmedic on 3 Nov. 2010
*4  Signed by PMDA on 29 Jul. 2004
 

Cooperative Arrangements

Cooperative Arrangements
Partner Type of Arrangement Documentation Date of Signature
Nation (Region) Organization
P.R.CHINA SFDA Memorandum of Understanding PDF Japanese/Chinese (PDF) Jan. 2009
PDF English translation (PDF)
 
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
EC : European Commission
EMA (Former EMEA) : European Medicines Agency
FDA : Food and Drug Administration
HSA : Health Sciences Authority
IMB : The Irish Medicines Board
MHRA : Medicines and Healthcare products Regulatory Agency
SFDA : State Food and Drug Administration
TGA : Therapeutic Goods Administration
   
MHLW : Ministry of Health, Labour and Welfare
PMDA : Pharmaceuticals and Medical Devices Agency