- Home >
- International Programs >
- International Arrangements
Confidential Agreements
| 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/EMA | Confidentiality Arrangement (extended) | (PDF) |
(PDF) |
2 Feb. 2013 |
| EC/EMA | Confidentiality Arrangement (extended) | (PDF) |
(PDF) |
2 Feb. 2012 | |
| EC | Confidentiality Arrangement | (PDF) |
(PDF) |
28 Oct. 2009*2 | |
| EC/EMEA | Confidentiality Arrangement | (PDF) |
(PDF) |
2 Feb. 2007 | |
| FRANCE | ANSM | Confidentiality Arrangement | (PDF) |
(PDF) |
28 Nov. 2012 |
| IRELAND | IMB | Confidentiality Arrangement | (PDF) |
(PDF) |
23 Oct. 2011 |
| ITALY | AIFA | Confidentiality Arrangement | (PDF) |
(PDF) |
26 Nov. 2012 |
| SINGAPORE | HSA | Confidentiality Arrangement | (PDF) |
(PDF) |
13 May 2010 |
| SWITZERLAND | Swissmedic | Confidentiality Arrangement | (PDF) |
(PDF) |
7 Nov. 2010*3 |
| UK | MHRA | Memorandum on Information Exchange | (PDF) |
(PDF) |
14 Oct.2010 |
| USA | FDA | Confidentiality Commitment Statement | (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 Agreements
| Cooperative Arrangements | ||||
|---|---|---|---|---|
| Partner | Type of Arrangement | Documentation | Date of Signature | |
| Nation (Region) | Organization | |||
| P.R.CHINA | SFDA | Memorandum of Understanding | Japanese/Chinese (PDF) |
Jan. 2009 |
| 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 |