Chose a Country

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Africa

Algeria

East African Community

Ethiopia

Ghana

Kenya

South Africa

Tanzania

West African Health Organization 

Zazibona

Zimbabwe

Americas

Including North, Central and South America and the Caribbean


Argentina (ANMAT)

Brazil (ANVISA)

     ANVISA Priority Review

Canada 

Caribbean Regulatory System

Chile (ISPCH- ANAMED)

     ISP High Sanitary Priority

Colombia (INVIMA)

     INVIMA Abbreviated Route

     INVIMA Exceptional Circumstances

Costa Rica

Cuba (CECMED)

Dominican Republic

El Salvador

Haiti

Mexico (COFEPRIS)

Peru (DIGEMID)

Suriname

United States (FDA)

     FDA Accelerated Approval   

     FDA Breakthrough Therapy

     FDA CPP for Unapproved Products

     FDA Fast Track

     FDA Orphan Designation

     FDA Priority Review

     FDA Real Time Oncology Review-RTOR

     FDA Regenerative Medicine Advanced Therapy Designation

        

Asia

Including China, Japan, India, Antipodes


Australia (TGA)

     TGA COR-A

      TGA COR-B

China (NMPA)

India (CDSCO)

Indonesia (NADFC)

Japan (PMDA)

     PMDA Conditional and time limited authorization for regenerative therapies

     PMDA Conditional Early Approval

     PMDA Orphan

     PMDA Sakigake

Malaysia (NRPA)

Philippines (PFDA)

Singapore (HSA)

South Korea (MFDS)

Taiwan (Chinese Taipei) (TFDA)

Thailand (Thai FDA)

Vietnam (DAV)


Europe

Including mainland Europe, United Kingdom, Republic of Ireland, Scandinavia.


England (MHRA)

European Medicines Agency 

     EMA Accelerated Assessment

     EMA Adaptive Pathway (regulatory HTA parallel advice)

     EMA Advanced Therapy Medicinal Product

     EMA Article 58

     EMA Conditional Marketing Authorization

     EMA Exceptional Circumstances

     EMA Orphan Designation

     EMA PRIME

Switzerland (Swissmedic)

     Swisssmedic Marketing Authorization for Global Health Products (MAGHP)

Middle East and Gulf

Egypt

Gulf Cooperation Council (GCC)

Iran

Israel (MOH)

Saudi Arabia (SFDA)

Turkey (TITCK)

Other

World Health Organization (WHO)

     WHO Prequalification of Medicines Programme (PQP)

     WHO Abbreviated PQ Assessment

     WHO Collaborative Registration process