Search across 69,000+ products, devices, trials, documents, and organizations
| Type | Title & Description | Details | Country | Status |
|---|---|---|---|---|
| Training |
Production and in process control (In-person)
NRA
|
●
Ethiopia
|
Planning | |
| Training |
Product conformity assessment (In-person)
NRA
|
●
South Africa
|
Planning | |
| Training |
Product Risk Classification (Hybrid)
NRA
|
●
South Africa
|
Planning | |
| Organization |
South African Health Products Regulatory Authority (SAHPRA)
2
|
Cat: 2
|
— | — |
| Product |
-SINURHON_ COMBINATION PRODUCT TABLET
|
Mfr: LEBEN LABORATORIES PVT. LTD.
|
●
MALAWI
|
APPROVED |
| Product |
1/2DS COMBINATION PRODUCT IV INFUSION
|
Mfr: ABACUS PARENTERAL DRUGS LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
4-CS COMBINATION PRODUCT SYRUP
|
Mfr: CAPS (PRIVATE) LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
A.P.C COMBINATION PRODUCT TABLET
|
Mfr: UNIVERSAL CORPORATION LTD
|
●
MALAWI
|
APPROVED |
| Product |
AAVI_GRIPE COMBINATION PRODUCT LIQUID
|
Mfr: AAVI MEDICARE PVT LTD
|
●
MALAWI
|
APPROVED |
| Product |
AAVIKOF COMBINATION PRODUCT COUGH SYRUP
|
Mfr: AAVI MEDICARE PVT LTD AT BIOHERBAL REMEDIES LTD
|
●
MALAWI
|
APPROVED |
| Product |
ACIDEX COMBINATION PRODUCT TABLET
|
Mfr: MALAWI PHARMACIES LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ACTCID COMBINATION PRODUCT TABLET
|
Mfr: UNIVERSAL CORPORATION (K) LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ACTIFIED COMBINATION PRODUCT SYRUP
|
Mfr: GLAXO WELLCOME OPERATIONS UK LTD
|
●
MALAWI
|
APPROVED |
| Product |
ACTIFIED COMBINATION PRODUCT TABLET
|
Mfr: GLAXO WELLCOME OPERATIONS UK LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ACTIFIED-CO COMBINATION PRODUCT LINCTUS
|
Mfr: GLAXO WELLCOME OPERATIONS UK LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ACTIHIST_CO COMBINATION PRODUCT SYRUP
|
Mfr: HOVID BDH, IPOH
|
●
MALAWI
|
APPROVED |
| Product |
ACTILOSA COMBINATION PRODUCT CAPSULE
|
Mfr: CACHET PHARMACEUTICALS PVT LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ACTILOSA_DS COMBINATION PRODUCT DRY SUSPENSION
|
Mfr: CACHET PHARMACEUTICALS PVT LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ACTILYF COMBINATION PRODUCT CAPSULES
|
Mfr: INDCHEMIE HEALTH SPECIALITIES PVT LTD
|
●
MALAWI
|
APPROVED |
| Product |
ACTION- COMBINATION PRODUCT TABLET
|
Mfr: BETA HEALTHCARE INTERNATIONAL LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ADCO-SODASOL COMBINATION PRODUCT EFFERVESCENT GRANULES
|
Mfr: QUATROMED LIMITED
|
●
MALAWI
|
APPROVED |
| Product |
ADVIL-CS COMBINATION PRODUCT TABLET
|
Mfr: WHITEHALL SOUTH AFRICA
|
●
MALAWI
|
APPROVED |
| Product |
AFTERBIRTH COMBINATION PRODUCT PESSARY
|
Mfr: PREMIER PHARMACEUTICALS
|
●
MALAWI
|
APPROVED |
| Product |
AIR PRODUCTS MEDICAL OXYGEN (GASEOUS)
|
— | APPROVED | |
| Product |
AIR PRODUCTS MEDICAL OXYGEN (LIQUID)
|
— | APPROVED | |
| Product |
AJANTA_STAMINA COMBINATION PRODUCT CAPSULE
|
Mfr: AJANTA PHARMA LTD
|
●
MALAWI
|
APPROVED |
| Product |
ALAXIN-PLUS COMBINATION PRODUCT TABLET
|
Mfr: BLISS GVS PHARMA LTD.
|
●
MALAWI
|
APPROVED |
| Product |
ALISERYL_WS COMBINATION PRODUCT POWDER FOR RECONSTITUTION
|
Mfr: INTERCHEMIE WERKENVDE ADELAAR BV
|
●
MALAWI
|
APPROVED |
| Pharmacovigilance |
Transfusion Reaction to Blood Product
Biologics - National Blood Service - Healthcare Professional
|
Mfr: National Blood Service
Cat: Biologics
Type: Biologics
Source: Healthcare Professional
|
●
Kenya
|
PENDING |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (In-person)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (In-person)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (Hybrid)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (Hybrid)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (Hybrid)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (Hybrid)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (In-person)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (In-person)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (In-person)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (In-person)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (Hybrid)
NRA
|
●
Algeria
|
Identified | |
| Training |
the staff of the physicochemical control department of pharmaceutical products of the physicochemical control department of pharmaceutical products. (Hybrid)
NRA
|
●
Algeria
|
Identified | |
| Training |
Supplier qualification ,Validation master plan ,Annual product review ,Complain and recall ,Self inspection ,Training ,Sop of sops ,Change control ,Medical examination (In-person)
NRA
|
●
Ethiopia
|
Identified | |
| Training |
Safe Disposal of Obsolete Products (In-person)
NRA
|
●
Uganda
|
Identified | |
| Training |
Medical device – standards and link to product evaluation (Online)
NRA
|
●
South Africa
|
Identified | |
| Training |
Advances therapy medicinal products (ATMP) (Hybrid)
NRA
|
●
Ethiopia
|
Planning | |
| Training |
Inspection of medical devices, cosmetics or therapeutic use, hygiene products related establishments (Hybrid)
NRA
|
●
Madagascar
|
Planning | |
| Training |
Advertising and promotion of health products regulations (Online)
NRA
|
●
Madagascar
|
Planning | |
| Training |
Marketing applications for biological products (vaccines) (Hybrid)
NRA
|
●
Cape Verde
|
Planning | |
| Training |
Marketing applications for biological products (vaccines) (Hybrid)
NRA
|
●
Burkina Faso
|
Planning | |
| Training |
Haemovigilance in clinical trials and other post authorised drug products (In-person)
NRA
|
●
Uganda
|
Planning | |
| Training |
Clinical trials assesment involving vaccines and other biological products (In-person)
NRA
|
●
Uganda
|
Planning | |
| Training |
Blood and blood products quality control (In-person)
NRA
|
●
Uganda
|
Planning | |
| Training |
Medical device � standards and link to product evaluation (Online)
NRA
|
●
South Africa
|
Planning | |
| Training |
Cell substrates used for Biotech Products (In-person)
NRA
|
●
South Africa
|
Planning | |
| Training |
Medical products registration and evaluation (In-person)
NRA
|
●
Seychelles
|
Planning | |
| Training |
Marketing applications for biological products (vaccines) (Hybrid)
NRA
|
●
Mozambique
|
Planning | |
| Training |
Good Manufaturing Pratice for Biological products and vaccines (In-person)
NRA
|
●
Mozambique
|
Planning | |
| Training |
Marketing applications for biological products (vaccines) (Hybrid)
NRA
|
●
Mozambique
|
Planning | |
| Training |
Good Manufaturing Pratice for Biological products and vaccines (In-person)
NRA
|
●
Mozambique
|
Planning | |
| Training |
Good Manufaturing Pratice for Biological products and vaccines (In-person)
NRA
|
●
Mozambique
|
Planning | |
| Training |
Manufacturing of advanced therapy medicinal products regulatory (Hybrid)
NRA
|
●
Algeria
|
Planning | |
| Training |
Sampling of pharmaceutical products and medical devices (Online)
NRA
|
●
Algeria
|
Planning | |
| Resource |
AU Model Law on Medical Products Regulation – French
AU Model Law multilingual versions
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
AU Model Law on Medical Products Regulation – Arabic
AU Model Law multilingual versions
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
AU Model Law on Medical Products Regulation – Portuguese
AU Model Law multilingual versions
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
NAFDAC Public Alert No. 010/2025 – Fake “Wonder Calcium” product (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
|
Cat: News & Regulatory Alerts (Africa Medicines Regulation)
|
— | — |
| Resource |
MCAZ – Warning: “Handy Heroes” (adulterated product alert) (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
|
Cat: News & Regulatory Alerts (Africa Medicines Regulation)
|
— | — |
| Resource |
TMDA Public Notice – Expression of Interest: Evaluators of Medicinal Products and Medical Devices (2024)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
|
Cat: News & Regulatory Alerts (Africa Medicines Regulation)
|
— | — |
| Resource |
AMRH – Call for industry applications: Pilot of continental listing of medicinal products (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
|
Cat: News & Regulatory Alerts (Africa Medicines Regulation)
|
— | — |
| Resource |
AMRH – Call for industry applications: Mpox candidate medicinal products (expedited evaluation) (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
|
Cat: News & Regulatory Alerts (Africa Medicines Regulation)
|
— | — |
| Resource |
Applicants: Biotherapeutic Products (EMP-TC guidance PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
CTD Product Dossier Guideline (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Renewal of Registered Human Pharma Products (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Compendium: Marketing Authorisation of Medicinal Products (PDF, July 2020)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Applicants: Biosimilar Products (EMP-TC guidance PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Guidance: Eligibility Criteria for Priority Products (AMRH)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Guidelines: Registration of Drug Products Made in Nigeria (2025 PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Guidelines: Registration of Imported Drug Products (2025 PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Guidelines: Variations on Registered Medicinal Products (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Call: Pilot of Continental Listing of Medicinal Products (AMRH)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Guidelines: Labelling Format/Content for Medicinal Products (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Guidelines: Import/Export of Pharma Products & Raw Materials (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Call: Mpox Candidate Medicinal Products – Expedited Evaluation
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Kenya health products registration rules (Legal Notice, PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Trial |
A multi-country, multi-centre, two arm, parallel, double blind, placebo- controlled, randomized trial of antenatal corticosteriods for women at risk of imminent birth in the late preterm period in hospitals in low resource countries to improve newborn out
Drug - Department of Reproductive Health & Research, World Health Organisation - Dr Adejumoke Idowu Ayede
|
Mfr: Department of Reproductive Health & Research, World Health Organisation
Applicant: Dr Adejumoke Idowu Ayede
Sponsor: Department of Reproductive Health & Research, World Health Organisation
Cat: Drug
Type: Drug
|
— | Approved |
| Trial |
A phase III, randomised, double-blind, active, controlled, multinational, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering v
Drug - Department of Reproductive Health & Research, World Health Organization - Dr Bukola Fawole
|
Mfr: Department of Reproductive Health & Research, World Health Organization
Applicant: Dr Bukola Fawole
Sponsor: Department of Reproductive Health & Research, World Health Organization
Cat: Drug
Type: Drug
|
— | Approved |
| Trial |
A phase III, randomized, double blind, active, controlled, multi national, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of post partum haemorrhage during the third stage of labour in women delivering
Drug - Department of Reproductive Heath & Research, World Health Organization - Dr Bukola Fawole
|
Mfr: Department of Reproductive Heath & Research, World Health Organization
Applicant: Dr Bukola Fawole
Sponsor: Department of Reproductive Heath & Research, World Health Organization
Cat: Drug
Type: Drug
|
— | Approved |
| Device |
Disposable Bedpan
Patient Care Products - Class A - Bedpan, disposable
|
Mfr: Hygiene Medical Products
Cat: Class A
|
●
Algeria
|
PENDING |
| Resource |
AU Model Law – Overview Page
Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
AU Model Law (PDF)
Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
AU Model Law (Annotated Copy)
Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
PATH Policy Brief on AU Model Law
Continental legal and policy frameworks supporting harmonised regulation of medical products, including the AU Model Law and supporting policy briefs.
|
Cat: AU Model Law & Continental Regulatory Policy Instruments
|
— | — |
| Resource |
African Medicines Quality Forum (AMQF-TC)
Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.
|
Cat: Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)
|
— | — |
| Resource |
AMQF Pharmaceutical Laboratory Equipment Management Guideline (PDF, 2024)
Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.
|
Cat: Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)
|
— | — |
| Resource |
USP PQM+ – AMQF Overview
Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.
|
Cat: Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)
|
— | — |
| Resource |
EDQM–Africa Regulatory Strengthening
Resources supporting medicines quality assurance, pharmacovigilance, post-market surveillance and combating substandard/falsified medical products.
|
Cat: Medicines Quality, Pharmacovigilance & Surveillance (AMQF and related)
|
— | — |
| Product |
Mfr: CENTAUR PHARMACEUTICALS PVT. LTD.
|
●
BOTSWANA
|
APPROVED | |
| Product |
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE
|
Mfr: CIPLA LIMITED
|
●
UGANDA
|
APPROVED |
| Product |
ACIDIC STOMACH BALANCE
|
Mfr: BELL LIFESTYLE PRODUCTS INC
|
●
ZIMBABWE
|
APPROVED |
| Product |
ACTEMRA 200
|
Mfr: CHUGAI PHARMA MANUFACTURING CO. LTD
|
●
ZIMBABWE
|
APPROVED |
| Product |
ACTEMRA 200
|
— | APPROVED | |
| Product |
ACTEMRA 400
|
— | APPROVED | |
| Product |
ACTEMRA 400
|
Mfr: CHUGAI PHARMA MANUFACTURING CO. LTD
|
●
ZIMBABWE
|
APPROVED |
| Product |
ACTEMRA 80
|
— | APPROVED | |
| Product |
ACTEMRA 80
|
Mfr: CHUGAI PHARMA MANUFACTURING CO. LTD
|
●
ZIMBABWE
|
APPROVED |
| Product |
ACTEMRA SC
|
— | APPROVED | |
| Product |
ACTRAPHANE HM (GE) 30/70 PENSET, 3ML
|
Mfr: 1.NOVO NORDISK A/S ,NOVO ALLÉ, DK-2880 BAGSVÆRD, DENMARK.
2. NOVO NORDISK PRODUCTION SAS 45, AVENUE D’ORLÉANS, F-28002 CHARTRES, FRANCE. (ADDITIONAL SITE FOR BOT1302418A/B)
3.NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTD
AVENIDA C, 1413
DISTRITO IND
|
●
BOTSWANA
|
APPROVED |
| Product |
ACTRAPHANE-HM 100IU/ML INJECTION
|
Mfr: NOVO NORDISK A/S & NOVO NORDISK PRODUCTION SAS & DO BRASIL LTD
|
●
MALAWI
|
APPROVED |
| Product |
ACTRAPID
|
Mfr: NOVO NORDISK
|
●
UGANDA
|
APPROVED |
| Product |
ACTRAPID - INSULIN HUMAN RDNA - 100 IU/ML - SOLUTION FOR INJECTION
|
Mfr: NOVO NORDISK PRODUCTION SAS(FRANCE)
|
●
ETHIOPIA
|
APPROVED |
| Product |
ACTRAPID 100IU/ML INJECTION
|
Mfr: NOVO NORDISK A/S & NOVO NORDISK PRODUCTION SAS & DO BRASIL LTD
|
●
MALAWI
|
APPROVED |
| Product |
ACTRAPID FLEXPEN 100 I.U/ML
|
Mfr: NOVO NORDISK
|
●
UGANDA
|
APPROVED |
| Product |
ACTRAPID HM (GE) 100IU/ML PENSET, 3ML
|
Mfr: 1.NOVO NORDISK A/S ,NOVO ALLÉ, DK-2880 BAGSVÆRD, DENMARK.
2. NOVO NORDISK PRODUCTION SAS 45, AVENUE D’ORLÉANS, F-28002 CHARTRES, FRANCE. (ADDITIONAL SITE FOR BOT1302418A/B)
3.NOVO NORDISK PRODUCAO FARMACEUTICA DO BRASIL LTD
AVENIDA C, 1413
DISTRITO IND
|
●
BOTSWANA
|
APPROVED |
| Product |
ADCO-WINLOMYLON
|
Mfr: STERLING PRODUCTS INTERNATIONAL INC
|
●
ZIMBABWE
|
APPROVED |
| Product |
ALAACOS SANITARY PADS
|
Mfr: QUANZHOU ERA SANITARY PRODUCTS CO.
|
— | APPROVED |
| Product |
ALBEX PLUS®
|
Mfr: MEDMAC FOR MANUFACTURING AGRICULTURAL CHEMICALS & VETERINARY PRODUCTS LTD.
|
●
UGANDA
|
APPROVED |
| Product |
ALBUSOL 20 %
|
— | APPROVED | |
| Product |
ALBUSOL 20% IV INFUSION
|
Mfr: NATIONAL BIOPRODUCTS, RSA
|
●
BOTSWANA
|
APPROVED |
| Product |
ALBUSOL 4 %
|
— | APPROVED | |
| Product |
ALBUSOL 4% IV INFUSION
|
Mfr: NATIONAL BIOPRODUCTS, RSA
|
●
BOTSWANA
|
APPROVED |
| Product |
ALECENSA
|
— | APPROVED | |
| Product |
ALILOMA 100
|
— | APPROVED | |
| Device |
Abbott RealTime HBV
Collection Container Assembly Complete - Class D - 1
|
Mfr: NANJING LIMING BIO-PRODUCTS CO. LTD
Cat: Class D
|
●
Senegal
|
PENDING |
| Device |
CITIZEN DIGITAL BLOOD PRESSURE MONITOR (CH617/CH618)
ORTHOPAEDIC KNEE SUPPORTS WRAPS AND BRACES - Class A - 1
|
Mfr: M. SCHILLING GMBH MEDICAL PRODUCTS
Cat: Class A
|
●
Ethiopia
|
PENDING |
| Device |
CITIZEN EAR THERMOMETER (CTD504/CTD505)
Triangular Bandage - Class D - 1
|
Mfr: GUANGDONG MEDICINES AND HEALTH PRODUCTS IMP. & EXP. CO., LTD.
Cat: Class D
|
●
Zimbabwe
|
PENDING |
| Device |
DERMOL EMOLLIENT CREAM
Operation Table - Class A - 1
|
Mfr: NANJING LIMING BIO-PRODUCTS CO. LTD
Cat: Class A
|
●
Ghana
|
PENDING |
| Device |
EasyElectrolyte Analyzer
Silicone Cups - Class A - 1
|
Mfr: M. SCHILLING GMBH MEDICAL PRODUCTS
Cat: Class A
|
●
Ghana
|
PENDING |
| Device |
Laborex NT-proBNP Fast Test Kit
General Purpose Cytology Brush - Class A - 1
|
Mfr: NANJING LIMING BIO-PRODUCTS CO. LTD
Cat: Class A
|
●
Ethiopia
|
PENDING |
| Device |
Polyflon
GAUZE BANDAGE - Class D - 1
|
Mfr: M. SCHILLING GMBH MEDICAL PRODUCTS
Cat: Class D
|
●
Uganda
|
PENDING |
| Device |
Suction Catheter
Chest Drainage Device - Class B - 1
|
Mfr: GUANGDONG MEDICINES AND HEALTH PRODUCTS IMP. & EXP. CO., LTD.
Cat: Class B
|
●
Ethiopia
|
PENDING |
| Device |
UNIX PCN CATHETER & SET
Percussion Hammer - Class B - 1
|
Mfr: GUANGDONG MEDICINES AND HEALTH PRODUCTS IMP. & EXP. CO., LTD.
Cat: Class B
|
●
South Africa
|
PENDING |
| Resource |
WHO: Regional joint activities and work-sharing – landing
WHO global benchmarking tools, regulatory reliance references and international guidance frequently used by African NRAs and regional initiatives.
|
Cat: WHO & Global Benchmarking / Reliance Reference Materials
|
— | — |
| Resource |
WHO Regional Work-Sharing & Joint Reviews
WHO global benchmarking tools, regulatory reliance references and international guidance frequently used by African NRAs and regional initiatives.
|
Cat: WHO & Global Benchmarking / Reliance Reference Materials
|
— | — |
| Resource |
NAFDAC Public Alert No. 11/2025 – Recall by Sun Pharma/Glenmark/Zydus (2025)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
|
Cat: News & Regulatory Alerts (Africa Medicines Regulation)
|
— | — |
| Resource |
WHO – Regional joint activities and work-sharing (reference) (ongoing)
News, recalls, safety alerts, and press releases relevant to medicines regulation in Africa (NRA + partners).
|
Cat: News & Regulatory Alerts (Africa Medicines Regulation)
|
— | — |
| Resource |
EMP-TC Continental Procedure (AMRH publication page)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Marketing Authorisation: Procedural Aspects (Human Pharma) (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Rwanda medicines registration regulation draft (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
TMDA: Regulatory Reliance for Marketing Authorisation (PDF, July 2025)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |
| Resource |
Malawi PMRA: Fast Track Registration Guideline (PDF)
National regulatory authority guidance, laws, procedures, portals and publications (multi-language where available).
|
Cat: National Regulatory Authorities (NRAs) – Country Guidance & Publications
|
— | — |