The "Understanding FRPs" Project

 Through your expertise and experience, the global regulatory community can stay up to date with respect to FRPs as they are introduced and evolve. 

In order to help with maintaining a current library of FRPs, your help is greatly appreciated.  Download the  FRP Information Input Form  , fill it in where you think a new FRP should be created or to update information on an existing FRP and return it to info@frpath.org .  We'll take it from there to update the FRP's information.  Thanks!!

Click here to download the FRP Information Input Form

Chose a Country to Find an FRP

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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

Colombia (INVIMA)

     INVIMA Abbreviated Route

     INVIMA Exceptional Circumstances

Costa Rica

Canada 

Caribbean Regulatory System

Chile (ISPCH- ANAMED)

     ISP High Sanitary Priority

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)

Indonesia Path IV (new life saving drugs)

Indonesia Path V (prior approved)

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)

     Swissmedic Marketing Authorization for Global Health Products (MAGHP)

Middle East and Gulf

Egypt

Gulf Health Council (GHC)

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