FRPath | Africa Region FRPs

- Continental Listing of Medicinal Products (AMA)

- Autorisation Temporaire d’Utilisation (ATU)

- Expedited/Fast-track procedure
- Medicine Registration Exemption
- Non-Routine Assessment of Products for Public Health Emergencies

- EAC Medicines Regulatory Harmonization Program

- Joint assessments of applications for marketing authorization in the CEMAC zone

- Biological Products Reliance Pathway (decree 343/2021)
- Emergency Use Application & Approval (EUA) - Medicinal Products
- Emergency Use Application & Approval (EUA) - Biological Products
- Reliance pathway for post-approval changes to a registered biotherapeutic product
- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)
- Lot Release of Biological Products in Egypt

- Fast track/priority registration

- Fast track for locally manufactured and priority medicines
- Conditional Approval of Medicines
- Emergency Use Authorization of COVID-19 Vaccine
- Registration of Low-Risk Medicines

- Alternative/non routine authorization application pathways – VERIFICATION ROUTE
- Abridged Review
- Emergency Use Authorization (EUA) of Medical Products

- COVID-19 vaccine approval in India for restricted use in emergency situation

- IGAD Joint Assessment Procedure

- Reliance Procedure

- Fast track for locally manufactured and priority medicines
- Reliance for Regulatory Decision Making in Kenya
- Emergency Use Application (EUA)

- Registration of Medicines

- Verification Review
- Abridged Review

- Expedited “fast-track” registration procedure
- Verification Review
- Abridged Review

- Registration of Imported Drugs in Nigeria
- Licensing or Access to COVID-19 Vaccines

- Authorization for Emergency Use for Medicinal Products, Medical Devices and IVDs
- Priority Review (Biological Products)
- Priority Review

- Expedited/Fast-Track Review Process
- Listing of specialized or orphan products for importation in Sierra Leone
- Emergency Use Authorization

- Reliance-based Evaluation Pathways – ABRIDGED REVIEW
- Reliance-based Evaluation Pathways - RECOGNITION
- Reliance-based Evaluation Pathways – VERIFIED REVIEW
- Registration of Candidate COVID-19 vaccines
- EDA-SAHPRA Work Sharing Initiative (WSI) for Registration of Medical Products (Pilot Phase)

- Fast Track Evaluation
- Abridged Review
- Emergency Use Authorization of Medicinal Products
- Orphan Medicines

- Abridged Review

- Homologation procedure

- Prioritization Request

- NDA Abridged Evaluation Process
- Monitored Emergency Use of Unregistered Investigational Interventional Products (MEURI)
- Fast-track assessment of CTD dossier applications

- Licensing of Pharmaceuticals for Human Use in WAEMU Member States

- West African Health Organization (WAHO) Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products

- Verification Review (Type 1)
- Abridged review (Type 2)
- Fast-track/priority review

- ZAZIBONA Collaborative Medicines Registration Process - Cost Recovery Pilot

- Expedited or “Fast-track” Registration Procedure

Africa

Choose a country below to begin

African Medicines Agency (AMA)

Algeria

Botswana

East African Community (EAC)

Economic and Monetary Community of Central Africa (CEMAC)

Egypt

Eritrea

Ethiopia

Ghana

India

Intergovernmental Authority on Development (IGAD) Region

Ivory Coast

Kenya

Liberia

Mozambique

Namibia

Nigeria

Rwanda

Sierra Leone

South Africa

Tanzania

The Gambia

Togo

Tunisia

Uganda

West African Economic and Monetary Union (WAEMU)

West African Health Organization (WAHO)

Zambia

Zazibona

Zimbabwe