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 needed. The information in FRPath is verified to the best of our knowledge, and your input helps make it the most complete resource of its kind.   


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!!

Chose a Region to Find an FRP

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Africa


Algeria (SA)

East African Community Collavorative (EAC MRH) RRI

Ethiopia Fast Track (EFDA)

Gambia (MCA)

Ghana (FDAG)

   Non-routine verification pathway

   Non-routine reliance pathway

Kenya Fast Track (PPB)

Nigeria (NAFDAC)

Senegal (MoH)

South Africa (SAHPRA)

   Abridged recognition pathway

   Abridged reliance pathway

   Abridged verification pathway

Tanzania Fast Track (TMMDA)

Tunisia (DPM)

Uganda Abridged Procedure (UNDA)

West African Health Organization Joint Assmt (WAHO) RRI

Zambia (ZAMRA)               

Zazibona Centralized RRI (Zazibona)

Zimbabwe Fast Track (MCAZ)

South America 


Argentina (ANMAT)

   Article 3 fast track

   Article 4 Fast track

Brazil (ANVISA)

   ANVISA Priority Review

   ANVISA Biosimilar reliance pathway

Chile (ISPCH-ANAMED)

    Priority simplified

    Priority short

Colombia (INVIMA)

     Abbreviated Route

     Exceptional Circumstances

Peru Reliance pathway (DIGEMID)

Suriname (MoH) 

Uruguay Expedited pathway  (MSP)    


Central America and Caribbean


Caribbean Regulatory System centralized (CRS)

Costa Rica  (MDS)

   MDS Fast Track

   MDS Reliance pathway

Cuba Expedited pathway (CECMED)

Dominican Republic (DGDP)

Ecuador (ARCSA)

El Salvador (NDD)

Guatemala (MSPAS)

Mexico (COFEPRIS)

   Expedited review pathway

   Rare disease pathway

   Equivalence agreement

Honduras (ARSA)

Haiti (MSPP/DMPMT)

Panama (MINSA)

North America


Canada (TPD)


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


ASEAN SIAHR RRI

Australia (TGA)

     TGA COR-A

      TGA COR-B

Indonesia (NADFC)

     Indonesia Path IV (new life saving drugs)

     Indonesia Path V (prior approved)

Malaysia (NPRA)

Pakistan (DRAP)

   Pakistan Priority

   Pakistan Conditional Marketing Authorization

Philippines FRP (PDEA)

Singapore (HSA)

   Singapore CECA Procedure

   Singapore GDA Verification

   Singapore GDA Abridged

   Singapore NDA Verification

   Singapore NDA Abridged

South Korea (MFDS)

Taiwan (Chinese Taipei) (TFDA)

Thailand Abridged (Thai FDA)

Vietnam Abridged (DAV)


 China-India-Japan


China Fast Track (NMPA)

India (CDSCO)

Japan (PMDA)

     PMDA Conditional and time limited authorization for regenerative therapies     

     PMDA Conditional Early Approval

     PMDA Orphan

     PMDA Sakigake


Eurasia


Eurasian Economic Union (EAEU)

   Mutual Recognition Procedure

   Decentralized Procedure

Kazakhstan (NCM)

Serbia (MMDAS- ALIMS)

Ukraine (MoH)

     Authenticity Review

     Expedited Review procedure


Europe and UK


England (MHRA)

European Medicines Agency (EMA)

     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 Fast Track (EDA)

Gulf Health Council RRI (GHC)

Iran (FDAIran)

Israel (MOH)

Jordan

   Jordan Abridged

   Jordan Verification

Kuwait Reliance pathway (MoH) 

Saudi Arabia (SFDA)

   Saudi Abridged

   Saudi Verification

Turkey Priority Assessment (TITCK)

United Arab Emirates fast Track (MoH)

Others


World Health Organization (WHO)

    WHO accelerated assessment with Prior SRA approval   

    WHO Accelerated registration for Prequalification 

    WHO PQP Abridged Assessment

    WHO PQP Full assessment

     WHO Collaborative Registration process