Bilateral Arrangements

Bilateral Cooperation between MHLW/PMDA and Foreign Regulatory Authorities

 

Confidential Arrangements

1. Regulatory Authorities

Australia (TGA)
Confidentiality Arrangement (6 September 2011)

• Document from Japan [429.62KB]
• Document to Japan [386.22KB]

Brazil (ANVISA)
Confidentiality Arrangement (26 November 2012)

• Document from Japan [1.20MB]
• Document to Japan [1.11MB]

Canada (Health Canada)
Confidentiality Arrangement (9 October 2009)

• Document from Japan [378.84KB]
• Document to Japan [374.27KB]

Denmark (DKMA)
Confidentiality Arrangement (2 May 2018)

• Document from Japan [144.88KB]
• Document to Japan [131.93KB]

EU (EC / EMA)
EC - Confidentiality Arrangement（Medical Device, extended）(6 July 2015 ^{Note 1})

• Document from Japan [107.16KB]

• Document to Japan [158.07KB]

EC - Confidentiality Arrangement（Cosmetics）(6 July 2015 ^{Note 1})

• Document from Japan [100.41KB]

• Document to Japan [150.62KB]

EC/EMA - Confidentiality Arrangement (extended) (2 February 2013)

• Document from Japan [1.51MB]

• Document to Japan [1.60MB]

France (ANSM)
Confidentiality Arrangement (28 November 2012)

• Document from Japan [1.62MB]
• Document to Japan [1.38MB]

Ireland (IMB (currently HPRA))
Confidentiality Arrangement (23 October 2011)

• Document from Japan [369.71KB]
• Document to Japan [1.01MB]

Italy (AIFA)
Confidentiality Arrangement (26 November 2012)

• Document from Japan [1.28MB]
• Document to Japan [1.25MB]

Neitherland (MEB)
Confidentiality Arrangement (20 November 2014)

• Document from Japan [424.83KB]
• Document to Japan [922.43KB]

Poland (URPL WMiPB)
Confidentiality Arrangement (23 October 2017)

• Document from Japan [102.98KB]
• Document to Japan [107.77KB]

Singapore (HSA)
Memorandum on Information Exchange (13 May 2010)

• Document from Japan [133.09KB]
• Document to Japan [133.09KB]

Sweden (MPA)
Confidentiality Arrangement (28 June 2017)

• Document from Japan [103.41KB]
• Document to Japan [107.44KB]

Switzerland (Swissmedic)
Confidentiality Arrangement (7 November 2010 ^{Note 2})

• Document from Japan [338.15KB]
• Document to Japan [527.08KB]

UK (MHRA)
Confidentiality Arrangement (14 October 2010)

• Document from Japan [1.08MB]
• Document to Japan [1.15MB]

US (US FDA)
Confidentiality Commitment Statement (15 September 2004 ^{Note 3})

• Document from Japan [116.11KB]
• Document to Japan [103.68KB]

Note 1: Signed by EC on 14 July 2015
Note 2: Signed by Swissmedic on 3 November 2010
Note 3: Signed by MHLW on 23 July 2024 and by PMDA on 29 July 2004

2. International Organizations

EDQM of the Council of Europe

Confidentiality Arrangement (13 September 2016)

• Document from Japan [101.39KB]
• Document to Japan [86.59KB]

USP
Confidentiality Arrangement (20 June 2017)

• Document from Japan [105.33KB]
• Document to Japan [106.20KB]

WHO
Confidentiality Arrangement (7 October 2016 ^{Note 4})

• Document from Japan [341.50KB]
• Document to Japan [339.49KB]

Note 4: Signed by PMDA on 13 October 2016

 

Memorandum of Understanding/Memorandum of Cooperation

1. Regulatory Authorities

Brazil (ANVISA)
Memorandum of Cooperation (September 2015)

• Japanese document [121.57KB]
• English document [15.17KB]

China (SFDA¹ (currently NMPA))
Memorandum of Understanding (January 2009)

• Japanese / Chinese document [138.87KB]
• English translated document [32.68KB]

India (CDSCO)
Memorandum of Cooperation (December 2015)

• Japanese document [102.25KB]
• English document [42.47KB]

Indonesia (Indonesian FDA)
Memorandum of Cooperation (August 2021)

• Japanese document [438.00KB]
• English document [136.69KB]

Republic of Korea (MFDS)
Memorandum of Cooperation (August 2015)

• Japanese document [76.21KB]
• English document [15.65KB]

Saudi Arabia (SFDA²)
Memorandum of Cooperation (December 2020)

• Japanese document [794.97KB]
• English document [419.23KB]

Thailand (Thai FDA)
Memorandum of Cooperation (April 2018)

• Japanese document [119.50KB]
• English document [105.54KB]

 

2. International Organizations

EDQM of the Council of Europe
Memorandum of Cooperation (September 2016)

• Japanese document [107.37KB]
• English document [81.32KB]

ChP
Memorandum of Cooperation (September 2016)

• Japanese / Chinese document [200.32KB]
• English document [135.03KB]

USP
Memorandum of Cooperation (September 2016)

• Japanese document [125.10KB]
• English document [82.40KB]

 

Acronyms

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
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