RISP 2 is now live. We are actively updating country data to give you the most accurate view possible. If your data is not yet available, please reach out to nancyn@auda-nepad.org or mcneilm@auda-nepad.org.

Regulatory Information Sharing Platform - RISP

Connecting 55 African countries to achieve harmonized medical product regulation.

AI Assistant Products Devices Trials Documents Organizations Pharmacovigilance

Access regulatory information, trade intelligence, M&E insights, and comprehensive resources. Connect and share data seamlessly with authorities across 55 African countries for streamlined processes.

RISP Services

Professional medical regulation services across Africa

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Clinical Trials
Learn about trials
Medical Devices
Device registration
Events
28 African events

📰 Latest Updates from Partners & NRAs

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Partnership News

Landmark Agreement Among Africa's Leading National Medicines Regulatory Authorities

African regulatory authorities reach landmark agreement on mutual recognition, advancing harmonisation and supporting AMA operationalisation across th...

AUDA-NEPAD Communications • Dec 11
Regulatory Update

African Medicines Regulatory Harmonisation (AMRH) Strengthens Continental Systems

 Research

Malawi Strengthens Pharmaceutical Regulation Through PMRA

 Policy Change

NAFDAC Achieves Full Membership of the International Council for Harmonisation (ICH)

 Product Approval

Continental Listing: SOLIRIS

 Product Approval

Continental Listing: IMFINZI

Continental Regulatory Performance Dashboard

Real-time regulatory capacity monitoring across 55 African countries

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Strategic Insights & Recommendations

Real-time continental regulatory intelligence

WHO ML3+ Countries
9
Countries achieved WHO ML3+ status
ML3/4 Achievement Rate
16.7%
Of African countries at ML3/4
AMA Treaty Adoption
66.7%
Of countries signed AMA Treaty
Countries Signed AMA
36
Countries signed AMA Treaty
Active Partners
27
Active development partners
Continental Submissions
5
All-time submissions

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New registrations
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Activity Types

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Pharmaceutical 0
Medical Devices 0
Clinical Trials 0
Pharmacovigilance 0
Continental Listings 0

Regional Activity

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Pharmaceutical Products Pipeline

Country-level product registrations by status

Approved
69536

Insight: The registration pipeline shows pharmaceutical products across various approval stages. This data reveals regulatory capacity and efficiency at national levels, with status distribution indicating where bottlenecks may exist and where streamlining efforts should focus.

Clinical Trials Landscape

Research activity across trial phases

Phase I
10
Phase II
15
Phase III
10
Phase IV
2

Insight: 112 clinical trials demonstrate Africa's growing role in global pharmaceutical research. With 33 approved trials, the continent is building capacity for evidence-based medicine while ensuring local populations benefit from cutting-edge treatments.

Medical Devices by Risk Class

Distribution across safety classifications

Class A
106
Class B
100
Class D
85
Class C
60
Class I
2
Class IIa
1

Insight: Medical devices are registered across risk classifications (A=low to D=high risk). This distribution reflects regulatory sophistication in balancing patient safety with innovation access, with higher-risk devices requiring more stringent oversight.

Pharmacovigilance Safety Network

Adverse event reporting and monitoring

70
Total Reports
3
Reporting Countries
Serious
0
Non-Serious
70

Insight: Active pharmacovigilance across 3 countries demonstrates commitment to post-market safety surveillance. This reporting network enables rapid identification of safety signals, protecting public health while building confidence in regulatory systems.

Top Countries by Platform Activity

Combined engagement across all modules

Malawi
5880
Ethiopia
5772
Botswana
4283
Uganda
3822
Zimbabwe
3262
South Africa
183
Kenya
49
Tanzania
36

Insight: This cross-platform view aggregates activity from products, trials, devices, and pharmacovigilance, revealing which countries are most actively engaged with the RISP ecosystem. Higher activity indicates stronger regulatory infrastructure and commitment to harmonization.

Submissions by Category

Drugs
65%
Vaccines
20%
Devices
10%
Other
5%

Top Countries by Activity

1 🇳🇬 Nigeria 284
2 🇿🇦 South Africa 267
3 🇰🇪 Kenya 198
4 🇪🇬 Egypt 156
5 🇬🇭 Ghana 142