The "Understanding FRPs" Project

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)

AustralAsia

ASEAN SIAHR RRI

Australia (TGA)

     TGA COR-A

      TGA COR-B

      Priority pathway

Brunei Darussalam (MoH)

   Abridged pathway

Hong Kong (Drug Office)

   ATP Pathway

Indonesia (NADFC)

    Indonesia Path I (serious life threathening)

    Indonesia Path II (reference country)

     Indonesia Path IV (new life saving drugs)

     Indonesia Path V (prior approved)

Malaysia (NPRA)

    Verification pathway

    Abridged review

New Zealand

   Abbreviated pathway

   Priority pathway

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)

SriLanka (NMRA)

   Fast Track

   Priority Pathway

Taiwan (Chinese Taipei) (TFDA)

    Priority review

     Accelerated assessment

     Abbreviated review

Thailand Abridged (Thai FDA)

Vietnam Abridged (DAV)

 China-India-Japan

China (NMPA)

   Conditional pathway

   Priority pathway

   Breakthrough pathway

   Special product review

India (CDSCO)

Japan (PMDA)

     PMDA Conditional and time limited authorization for regenerative therapies     

     PMDA Conditional Early Approval

     PMDA Orphan

     PMDA Sakigake

Eurasia

Bhutan

   Abridged pathway

   Expedited pathway

Eurasian Economic Union (EAEU)

   Mutual Recognition Procedure

   Decentralized Procedure

Kazakhstan (NCM)

Moldova (MMDA)

   Priority pathway

Russia  (Roszdravnadzor)

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)     

     Article 13        

Middle East and Gulf

Egypt Fast Track (EDA)

Gulf Health Council RRI (GHC)

Iran (FDAIran)

Israel (MOH)

Jordan

   Jordan Abridged

   Jordan Verification

Kuwait (MoH)

   Accelerated Reliance pathway 

   Accelerated biosimilar pathway

Saudi Arabia (SFDA)

   Saudi Abridged

   Saudi Verification

Turkey Priority Assessment (TITCK)

United Arab Emirates fast Track (MoH)

North America

Canada (TPD)

     Priority pathway

     Notice of compliance with conditions (NOC/c)

United States (FDA)

     FDA Accelerated Approval   

     FDA Breakthrough Therapy

     FDA CPP for Unapproved Products

     FDA Fast Track

     FDA Orphan Designation

     FDA Priority Review

     Project Orbis

     FDA Real Time Oncology Review-   RTOR

     FDA Regenerative Medicine Advanced Therapy Designation          

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

    High sanitary priority for Orphan products

Colombia (INVIMA)

     Abbreviated Route

     Exceptional Circumstances

Ecuador (ARCSA)

Peru Reliance pathway (DIGEMID)

Suriname (MoH) 

Uruguay Expedited pathway  (MSP)    

Central America and Caribbean

Caribbean Regulatory System centralized (CRS)

Costa Rica  (MDS)

   Mutual recognition pathway

Cuba Expedited pathway (CECMED)

Dominican Republic (DGDP)

Ecuador (ARCSA)

El Salvador (NDD)

Guatemala (MSPAS)

Haiti (MSPP/DMPMT)

Honduras (ARSA)

Mexico (COFEPRIS)

   Expedited recognition pathway

   Article 170 pathway

   Equivalence agreement

Panama (MINSA)

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