Bilateral Cooperation between MHLW/PMDA and Foreign Regulatory Authorities
Confidential Arrangements
- Regulatory Authorities
*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 |
- International Organizations
*1 | Signed by PMDA on | 13 Oct. 2016 |
Memorandum of Understanding/Memorandum of Cooperation
- Regulatory Authorities
Cooperative Arrangements | ||||
---|---|---|---|---|
Partner | Type of Arrangement | Documentation | Date of Signature | |
Nation (Region) | Organization | |||
Brazil | ANVISA | Memorandum of Cooperation | Japanese | Sep. 2015 |
English | ||||
China | SFDA1 (currently NMPA) |
Memorandum of Understanding | Japanese/Chinese | Jan. 2009 |
English translation | ||||
India | CDSCO | Memorandum of Cooperation | Japanese | Dec. 2015 |
English | ||||
Indonesia | Indonesian FDA | Memorandum of Cooperation | Japanese | Aug. 2021 |
English | ||||
Republic of Korea | MFDS | Memorandum of Cooperation | Japanese | Aug. 2015 |
English | ||||
Saudi Arabia | SFDA2 | Memorandum of Cooperation | Japanese | Dec. 2020 |
English | ||||
Thailand | Thai FDA | Memorandum of Cooperation | Japanese | April 2018 |
English |
- 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 |
UK : | United Kingdom of Great Britain and Northern Ireland |
USA : | 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 Regulatory Agency |
CDSCO : | Central Drugs Standard Control Organization |
CFDA : | China Food and Drug Administration |
ChP : | Chinese Pharmacopoeia Commission |
DKMA | Danish Medicines Agency |
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 |
Indonesian FDA : | Indonesian Food and Drug Authority |
MFDS : | Ministry of Food and Drug Safety |
MEB : | Medicines Evaluation Board |
MHRA : | Medicines and Healthcare products Regulatory Agency |
MEB : | Medicines Evaluation Board |
NMPA : | National Medical Products Administration |
MPA : | Medical Products Agency |
NPRA : | National Pharmaceutical Regulatory Agency |
SFDA1 : | State Food and Drug Administration |
SFDA2 : | Saudi Food and Drug Authority |
TGA : | Therapeutic Goods Administration |
URPLWMiPB : | Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
USP : | United States Pharmacopeial convention |
WHO : | World Health Organization |
MHLW : | Ministry of Health, Labour and Welfare |
PMDA : | Pharmaceuticals and Medical Devices Agency |