East African Community

The East African Community (EAC) is a regional intergovernmental organisation of 7 Partner States: The Republic of Burundi, the Democratic Republic of the Congo, the Republic of Kenya, the Republic of Rwanda, the Republic of South Sudan, the Republic of Uganda, and the United Republic of Tanzania, with its headquarters in Arusha, Tanzania.

East African Medicines Regulatory Harmonization (EAC-MRH)

DownloadDetails
PJ3 A new approach to an old problem: Overview of the EAC's Medicines Regulatory Harmonization initiative DownloadA new approach to an old problem: Overview of the EAC’s Medicines Regulatory Harmonization initiative
Published 12 August 2020
covid study A two-step molecular and sero-epidemiological cross-sectional study in the EAC on the Prevalence of SARS-CoV-2  DownloadA two-step molecular and sero-epidemiological cross-sectional study in the EAC on the Prevalence of SARS-CoV-2
In Patients with Signs and Symptoms of Severe Acute Respiratory Infection (SARI) between 1st November 2019 and 29th February 2020
gmp9 Active Pharmaceutical Ingredients  DownloadActive Pharmaceutical Ingredients
Annex 9 | EAC/TF-MED/GMP/FD/GDL/N1R0
md1 Africa Medical Devices Forum (AMDF) Reporting Form for Complaints for Medical Devices including In-Vitro Diagnostics DownloadAfrica Medical Devices Forum (AMDF) Reporting Form for Complaints for Medical Devices including In-Vitro Diagnostics
June 2020
Screenshot 2019-03-12 at 163717 All Hazard Health Emergency Preparedness Plan for United Republic of Tanzania  DownloadAll Hazard Health Emergency Preparedness Plan for United Republic of Tanzania
PART I
Screenshot 2019-03-12 at 163839 All Hazard Health Emergency Preparedness Plan for United Republic of Tanzania  DownloadAll Hazard Health Emergency Preparedness Plan for United Republic of Tanzania
PART II
gmp11 Application for EAC Joint GMP Inspection for Finished Pharmaceutical Products  and Active Pharmaceutical Ingredients Manufacturing Facilities DownloadApplication for EAC Joint GMP Inspection for Finished Pharmaceutical Products and Active Pharmaceutical Ingredients Manufacturing Facilities
EAC/TF-MED/GMP/FD/FOM/N13R0
vb11 Application for Variation to a Registered Pharmaceutical Product DownloadApplication for Variation to a Registered Pharmaceutical Product
EAC/TF-MED/MER/FD/ VARIATIONS /N1R0
vb7 Application for Variation to a Registered Vaccine DownloadApplication for Variation to a Registered Vaccine
EAC/TF-MED/MER/FD/ VACCINE/N1R0
mr2 Application Form DownloadApplication Form
Annex II
pv1 Application Form for Active Pharmaceutical Ingredient Master File (APIMF) in the EAC DownloadApplication Form for Active Pharmaceutical Ingredient Master File (APIMF) in the EAC
June 2020
md3 Application Form for Market Authorization of In-vitro Diagnostic Medical Devices  DownloadApplication Form for Market Authorization of In-vitro Diagnostic Medical Devices
June 2020
vb2 Application Form for Registration of Biotherapeutics and Similar Biotherapeutic Products DownloadApplication Form for Registration of Biotherapeutics and Similar Biotherapeutic Products
EAC/TF-MED/MER/FD/ BIOTHERAPEUTICS/N1R0
vb4 Application Form for Registration of Human Vaccine in EAC Partner States DownloadApplication Form for Registration of Human Vaccine in EAC Partner States
EAC/TF-MED/MER/FD/ VACCINE/N1R0
vb10 Application Form for Registration of Similar Biotherapeutic Products DownloadApplication Form for Registration of Similar Biotherapeutic Products
EAC/TF-MED/MER/FD/ BIOTHERAPEUTICS/N2R0
mr15 Authorization to access Certificate of Suitability (CEP) DownloadAuthorization to access Certificate of Suitability (CEP)
EAC/TF-MED/MER/FD/COM/N1R2
gmp7 Authorized Persons DownloadAuthorized Persons
Annex 7 | EAC/TF-MED/GMP/FD/GDL/N1R0
mr9 Bioequivalence Study Requirements for Different Dosage Forms DownloadBioequivalence Study Requirements for Different Dosage Forms
Annex II
mr17 Bioequivalence Trial Information (BTIF) DownloadBioequivalence Trial Information (BTIF)
Annex V | EAC/TF-MED/MER/FD/EQUIVALENCE/NR10
mr10 Biopharmaceutics Classification System (BCS) Based Biowaiver DownloadBiopharmaceutics Classification System (BCS) Based Biowaiver
Annex III
mr7 Biowaiver Application Form: Biopharmaceutics Classification System (BCS) DownloadBiowaiver Application Form: Biopharmaceutics Classification System (BCS)
EAC-MRH
gmp14 Checklist for EAC Joint GMP Document Evaluation for Finished Pharmaceutical Products & Active Pharmaceutical Ingredients Manufacturing Facilities DownloadChecklist for EAC Joint GMP Document Evaluation for Finished Pharmaceutical Products & Active Pharmaceutical Ingredients Manufacturing Facilities
EAC/TF-MED/GMP/FD/CLT/N1R0
md4 Classification Rule for In-vitro Diagnostic Devices DownloadClassification Rule for In-vitro Diagnostic Devices
June 2020
Screen Shot 2018-03-23 at 104545 Clinical Research & Development in EAC region DownloadClinical Research & Development in EAC region
By: Michael Makanga, Executive Director, EDCTP
PJ1 Coming together to improve access to medicines: the genesis of the East African Community's Medicines Regulatory Harmonization initiative DownloadComing together to improve access to medicines: the genesis of the East African Community’s Medicines Regulatory Harmonization initiative
Published: 12 August 2020
mr1 Compendium of Medicines Evaluation and Registration for Medicine Regulation and Harmonization in the EAC DownloadCompendium of Medicines Evaluation and Registration for Medicine Regulation and Harmonization in the EAC
March 2019
gmp4 Computerized Systems DownloadComputerized Systems
Annex 4 | EAC/TF-MED/GMP/FD/GDL/N1R0
pv2 Cover Letter for Active Pharmaceutical Ingredient Master File (APIMF) Application  DownloadCover Letter for Active Pharmaceutical Ingredient Master File (APIMF) Application
June 2020
mr13 Cover Letter for Finished Pharmaceutical Products (FPP) Application DownloadCover Letter for Finished Pharmaceutical Products (FPP) Application
EAC/TF-MED/MER/FD/COM/N1R2
Screenshot 2021-03-12 at 122243 COVID-19 Pandemic Preparedness and Response Training of Trainers for Staff at 10 International Airports in the 6 EAC Partner States DownloadCOVID-19 Pandemic Preparedness and Response Training of Trainers for Staff at 10 International Airports in the 6 EAC Partner States
Report by CASSOA | March 2021
Screenshot 2019-07-29 at 124354 Cross Border Field Simulation Exercise at Namanga DownloadCross Border Field Simulation Exercise at Namanga
11-14 June 2019 | Report of the FSX
Screenshot 2019-09-16 at 164155 Cross-border Surveillance in the EAC Region DownloadCross-border Surveillance in the EAC Region
One Region – One Vision – One Health
Screenshot 2018-11-26 at 090946 Digital REACH Initiative Strategic Plan 2019 - 2028 DownloadDigital REACH Initiative Strategic Plan 2019 – 2028
Digital Regional East African Community Health Initiative |
Screen Shot 2018-03-23 at 105309 Digital Regional East African Community Health (REACH) Initiative  DownloadDigital Regional East African Community Health (REACH) Initiative
By: Gibson Kibiki, Executive Secretary, East African Health Research Commission
mr8 Dissolution Testing and Similarity of Dissolution Profiles DownloadDissolution Testing and Similarity of Dissolution Profiles
Annex I
mr20 EAC Common Glossary of Terms Used in Medicines Registration DownloadEAC Common Glossary of Terms Used in Medicines Registration
PART VII | EAC/TF-MED/MER/FD/GLOSSARY/NR10
Screenshot 2020-04-29 at 163445 EAC COVID-19 Response Plan DownloadEAC COVID-19 Response Plan
17 April 2020
Screenshot 2019-03-12 at 161252 EAC Cross Border Field Simulation Exercise (FSX) Namanga DownloadEAC Cross Border Field Simulation Exercise (FSX) Namanga
11-14 June 2019 | Briefing Document
Screenshot 2019-06-03 at 162055 EAC Cross Border Field Simulation Exercise (FSX) Namanga DownloadEAC Cross Border Field Simulation Exercise (FSX) Namanga
11-14 June 2019 | Frequently Asked Questions
Screenshot 2019-03-12 at 161618 EAC Cross Border Table Top Exercise  DownloadEAC Cross Border Table Top Exercise
04 – 05 September, 2018 | Workshop Report
md5 EAC Essential Requirements Checklist for In-Vitro Diagnostics DownloadEAC Essential Requirements Checklist for In-Vitro Diagnostics
June 2020
mr19 EAC Guidelines on Format and Content of Labels For Pharmaceutical Products DownloadEAC Guidelines on Format and Content of Labels For Pharmaceutical Products
PART V | EAC/TF-MED/MER/FD/LABELS/NR10
mr17 EAC Guidelines on Format and Content of Package Inserts for Pharmaceutical Products DownloadEAC Guidelines on Format and Content of Package Inserts for Pharmaceutical Products
PART VI | EAC/TF-MED/MER/FD/PIL/NR10
mr22 EAC Guidelines on Format and Content of Summary of Product Characteristics for Pharmaceutical Products DownloadEAC Guidelines on Format and Content of Summary of Product Characteristics for Pharmaceutical Products
PART IV | EAC/TF-MED/MER/FD/SmPC/N1R0
mr27 EAC Guidelines on Naming of Medicinal Products DownloadEAC Guidelines on Naming of Medicinal Products
PART XI | EAC/TF-MED/MER/FD/NAMING/N1R0
mr25 EAC Guidelines on Procedural Aspects for Applications for Marketing Authorization of Pharmaceutical Products DownloadEAC Guidelines on Procedural Aspects for Applications for Marketing Authorization of Pharmaceutical Products
PART X | EAC/TF-MED/MER/FD/MA/N1R0
mr24 EAC Guidelines on Registration of Fixed Dose Combination Pharmaceutical Products DownloadEAC Guidelines on Registration of Fixed Dose Combination Pharmaceutical Products
PART IX | EAC/TF-MED/MER/FD/FDC/N1R0
mr11 EAC Guidelines on Stability Testing Requirements for Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPP DownloadEAC Guidelines on Stability Testing Requirements for Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPP
EAC/TF-MED/MER/FD/STABILITY/N1R0
mr12 EAC Guidelines on Therapeutic Equivalence DownloadEAC Guidelines on Therapeutic Equivalence
EAC/TF-MED/MER/FD/EQUIVALENCE/N10
Screenshot 2019-06-27 at 153722 EAC Health Communication in the Media 2018 DownloadEAC Health Communication in the Media 2018
Support to Pandemic Preparedness in the EAC Region Project
Screenshot 2019-06-24 at 145153 EAC Health Communication in the Media 2019 DownloadEAC Health Communication in the Media 2019
Support to Pandemic Preparedness in the EAC Region Project
gmp12 EAC Health Sector Investment Framework DownloadEAC Health Sector Investment Framework
2018 – 2028
pl1 EAC Medicines and Health Technologies Policy DownloadEAC Medicines and Health Technologies Policy
February 2018
pl3 EAC Medicines and Health Technologies Strategic Plan (2018-2022) DownloadEAC Medicines and Health Technologies Strategic Plan (2018-2022)
February 2018
Screenshot 2021-11-22 at 123352 EAC Mobile Labs Project DownloadEAC Mobile Labs Project
Project Fact sheet 1
Screenshot 2021-11-22 at 152924 EAC Mobile Labs Project DownloadEAC Mobile Labs Project
Project Fact sheet 2
Screenshot 2019-09-16 at 161028 EAC One Health Regional Risk and Crisis Communication Strategy (2018/19 - 2022/23) DownloadEAC One Health Regional Risk and Crisis Communication Strategy (2018/19 – 2022/23)
‘One Health’ Risk and Crisis Communication Strategy
mr23 EAC Procedure on Evaluation of Quality of Active Pharmaceutical Ingredient  DownloadEAC Procedure on Evaluation of Quality of Active Pharmaceutical Ingredient
PART XII | EAC/TF-MED/MER/FD/QAPI/N1R0
Screenshot 2023-08-25 at 102545 EAC RCE -VIHSCM Newsletter - 7th Edition DownloadEAC RCE -VIHSCM Newsletter – 7th Edition
August 2023 | East African Community Regional Centre of Excellence for Vaccines, Immunization, and Health Supply Chain Management
Screenshot 2019-09-16 at 165011 EAC Regional Contingency Plan for Epidemics due to Communicable Diseases, Conditions and other events of Public Health Concern 2018 – 2023 DownloadEAC Regional Contingency Plan for Epidemics due to Communicable Diseases, Conditions and other events of Public Health Concern 2018 – 2023
Integrated disease prevention and control efforts in the EAC region
md7 EAC Regulatory Framework for Medical Devices including In-Vitro Diagnostic Medical Devices DownloadEAC Regulatory Framework for Medical Devices including In-Vitro Diagnostic Medical Devices
June 2020
md8 EAC Reporting Form for Variation of In-Vitro Diagnostics Device which has been issued Market Authorization DownloadEAC Reporting Form for Variation of In-Vitro Diagnostics Device which has been issued Market Authorization
June 2020
pv3 EAC Screening Template for Active Pharmaceutical Ingredient Master File (APIMF) DownloadEAC Screening Template for Active Pharmaceutical Ingredient Master File (APIMF)
June 2020
Screenshot 2019-06-28 at 120452 EAC Stakeholder Meeting for the Preparation of a Cross Border Field Simulation Excercise  DownloadEAC Stakeholder Meeting for the Preparation of a Cross Border Field Simulation Excercise
11 – 12 October 2018 | Meeting Report
Screenshot 2019-03-12 at 161618 EAC Stakeholder Meeting for the Preparation of a Cross Border Filed Simulation Exercise DownloadEAC Stakeholder Meeting for the Preparation of a Cross Border Filed Simulation Exercise
11 – 12 October 2018 | Workshop Report
pl2 EAC Technical Cooperation Framework Agreement for National Medicines Regulatory Authorities (NMRAs) DownloadEAC Technical Cooperation Framework Agreement for National Medicines Regulatory Authorities (NMRAs)
April 2018
scm-mrh-sp EAC-MRH Sustainability Plan (2021-2028) DownloadEAC-MRH Sustainability Plan (2021-2028)
EAC-MRH Sustainability Plan (2021-2028)
Screenshot 2020-05-21 at 114810 East Africa Science DownloadEast Africa Science
East Africa Science (EASci) Journal | Volume 2, Issue 1 | April 2020
Screenshot 2019-03-25 at 152624 East Africa Science DownloadEast Africa Science
East Africa Science (EASci) Journal | Volume 1, Issue 1 | March 2019
HRJ East African Health Research Journal | Volume 5, Issue 1 DownloadEast African Health Research Journal | Volume 5, Issue 1
East African Health Research Journal | Volume 5, Issue 1 | June 2021
Screen Shot 2017-06-19 at 153544 East African Health Research Journal  |  Volume 1, Issue 1 DownloadEast African Health Research Journal | Volume 1, Issue 1
East African Health Research Journal | Volume 1, Issue 1 | March 2017
screen_shot_2017-09-15_at_095120 East African Health Research Journal | Volume 1, Issue 2 DownloadEast African Health Research Journal | Volume 1, Issue 2
East African Health Research Journal | Volume 1, Issue 2 | July 2017
Screen Shot 2017-06-19 at 153913 East African Health Research Journal  |  Volume 1, Sup 1 DownloadEast African Health Research Journal | Volume 1, Sup 1
East African Health Research Journal | Volume 1, Sup 1 | March 2017
Screenshot 2019-08-19 at 095041 East African Health Research Journal | Volume 3, Issue 1 DownloadEast African Health Research Journal | Volume 3, Issue 1
East African Health Research Journal | Volume 3, Issue 1 | July 2019
Screenshot 2022-02-04 at 093356 East African Health Research Journal | Volume 3, Supplement 1 DownloadEast African Health Research Journal | Volume 3, Supplement 1
East African Health Research Journal | Volume 3, Supplement 1 | November 2021
Screen Shot 2018-04-30 at 092932 East African Health Research Journal | Volume 2, Issue 1 DownloadEast African Health Research Journal | Volume 2, Issue 1
East African Health Research Journal | Volume 2, Issue 1
EAHRJ Nov 2018 cover East African Health Research Journal | Volume 2, Issue 2 DownloadEast African Health Research Journal | Volume 2, Issue 2
East African Health Research Journal | Volume 2, Issue 2 | November 2018
Screen Shot 2018-03-23 at 111552 East Africa's Centers of Excellence for Skills and Tertiary Education in Biomedical Sciences  DownloadEast Africa’s Centers of Excellence for Skills and Tertiary Education in Biomedical Sciences
By: Ms. Sunita Pitamber, Director of Human Development, African Development Bank
PJ5 Eight years of the EAC Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned DownloadEight years of the EAC Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned
Published 12 August 2020
Screenshot 2019-09-16 at 164451 Establishing a Regional Pool of Rapidly Deployable Experts (“regional pool”) in the EAC DownloadEstablishing a Regional Pool of Rapidly Deployable Experts (“regional pool”) in the EAC
Integrated Disease Prevention and Control in the EAC
Screenshot 2022-11-03 at 123135 Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for DownloadEvaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for
Published 03 November 2022
Screenshot 2019-07-17 at 105420 Exercise Report for Cross Border Table Top Exercise DownloadExercise Report for Cross Border Table Top Exercise
4 – 5 September 2018 | A Fictitious Outbreak of Rift Valley Fever in Kenya and Tanzania
Screenshot 2019-03-12 at 162549 Exercise Report for Cross Border Table Top Exercise  DownloadExercise Report for Cross Border Table Top Exercise
04 – 05 September 2018 | Exercise Report
Screenshot 2019-06-28 at 112744 Field Simulation Excercise at Namanga Border DownloadField Simulation Excercise at Namanga Border
11 – 14 June 2019 | Background Paper
Screenshot 2019-06-27 at 160844 Fighting Ebola: Voices from the Frontline DownloadFighting Ebola: Voices from the Frontline
Documenting the experiences of East African deployed experts who volunteered to fight Ebola in West Africa
Screenshot 2019-06-28 at 120949 5th Joint Steering Group and Excercise Management Group Meeting to Evaluate the Cross Border Field Simulation Excercise held at Namanga Download5th Joint Steering Group and Excercise Management Group Meeting to Evaluate the Cross Border Field Simulation Excercise held at Namanga
17 – 18 June 2019 | Meeting Report
GMP Flow Chart- Revised Flow chart for EAC Joint GMP Inspection DownloadFlow chart for EAC Joint GMP Inspection
MRH – Good Manufacturing Practices
md2 Guidance on Assessment of Medical Devices including Diagnostic Tests Donations for in-Country use during Emergencies  DownloadGuidance on Assessment of Medical Devices including Diagnostic Tests Donations for in-Country use during Emergencies
Africa Medical Devices Forum (AMDF) | April 2020
mr28 Guideline for Abridged Procedure for the EAC Joint Assessment and Accelerated National Registration DownloadGuideline for Abridged Procedure for the EAC Joint Assessment and Accelerated National Registration
Pharmaceutical Products Approved by Stringent Regulatory Authorities and the World Health Organization -Prequalification Program (WHO PQ) | EAC/TF-MED/MER/FD/ ABRIDGED /N1R0
gmp13 Guideline for Preparation of Site Master File For Pharmaceutical Manufacturing Facilities DownloadGuideline for Preparation of Site Master File For Pharmaceutical Manufacturing Facilities
September 2014
vb9 Guidelines for Registration of Similar Biotherapeutic Products DownloadGuidelines for Registration of Similar Biotherapeutic Products
November 2017 | EAC/TF-MED/MER/FD/BIOTHERAPUTIC/N2R0
vb1 Guidelines for Submission of Documentation for Registration of Biotherapeutic Products DownloadGuidelines for Submission of Documentation for Registration of Biotherapeutic Products
November 2017 | EAC/TF-MED/FD//BIOTHERAPUTICS/N1R0
vb5 Guidelines for Variation to a Registered Finished Pharmaceutical Product  DownloadGuidelines for Variation to a Registered Finished Pharmaceutical Product
November 2017 | EAC/TF-MED/MER/FD/VARIATIONS/N1R0
gmpbasic Guidelines on Good Manufacturing Practice for Medicinal Products Use in the EAC DownloadGuidelines on Good Manufacturing Practice for Medicinal Products Use in the EAC
September 2014 | EAC/TF-MED/GMP/FD/GDL/N1R0
Screenshot 2022-04-05 at 132931 Guidelines on Safety and Vigilance of Medical Products and Health Technologies DownloadGuidelines on Safety and Vigilance of Medical Products and Health Technologies
EAC Harmonized Compendium on Safety and Vigilance of Medical Products and Health Technologies | March 2019
vb2 Guidelines on Submission of Documentation for Registration of Human Vaccines  DownloadGuidelines on Submission of Documentation for Registration of Human Vaccines
November 2017 | EAC/TF-MED/MER/FD/VACCINE/N1R0
vb6 Guidelines on Variations to Registered Vaccines DownloadGuidelines on Variations to Registered Vaccines
August 2019 | EAC/TF-MED/MER/FD/VACCINE/N2R0
Screenshot 2022-07-05 at 120736 Harmonized Indicators for Assessing and Monitoring Pharmacovigilance Systems in the East African Community Partner States: User Manual DownloadHarmonized Indicators for Assessing and Monitoring Pharmacovigilance Systems in the East African Community Partner States: User Manual
June 2016
gmp6 Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms DownloadHeating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms
Annex 6 | EAC/TF-MED/GMP/FD/GDL/N1R0
Screenshot 2019-09-16 at 161356 How to Develop Key Messages DownloadHow to Develop Key Messages
Standard Operating Procedure: Integrated Disease Prevention and Control in the EAC
Screenshot 2019-09-16 at 162756 How to Disseminate Continuous Information on Hazards DownloadHow to Disseminate Continuous Information on Hazards
Standard Operating Procedure: Integrated Disease Prevention and Control in the EAC
Screenshot 2019-09-16 at 163205 How to Engage and Involve Stakeholders DownloadHow to Engage and Involve Stakeholders
Standard Operating Procedure: Integrated Disease Prevention and Control in the EAC
Screenshot 2019-09-16 at 163317 How to Generate and Gain Approval for a Press Release DownloadHow to Generate and Gain Approval for a Press Release
Standard Operating Procedure: Integrated Disease Prevention and Control in the EAC
Screenshot 2019-09-16 at 163501 How to Manage Rumours DownloadHow to Manage Rumours
Standard Operating Procedure: Integrated Disease Prevention and Control in the EAC
cover HS classification reference for Vaccines and related supplies and equipment DownloadHS classification reference for Vaccines and related supplies and equipment
Guidance to facilitate cross-border movement of situationally critical medicines and vaccines , highlighting their existing HS classifications | Prepared jointly with the World Health Organization (WHO)
PJ2 Improving access to quality medicines in East Africa: An independent perspective on the EAC Medicines Regulatory Harmonization initiative  DownloadImproving access to quality medicines in East Africa: An independent perspective on the EAC Medicines Regulatory Harmonization initiative
Published 12 August 2020
vb8 Infographic for EAC Joint Assessment Procedure DownloadInfographic for EAC Joint Assessment Procedure
Infographic
Screen Shot 2018-03-23 at 105902 Investing in Transforming and Resilience Health: Building Infrastructure, Systems and Institutions for better Health & UHC DownloadInvesting in Transforming and Resilience Health: Building Infrastructure, Systems and Institutions for better Health & UHC
By: Delanyo Dovlo, World Health Organization (WHO)
Screenshot 2019-06-03 at 160717 Joint Cross Border Field Simulation Exercise (FSX) at Namanga DownloadJoint Cross Border Field Simulation Exercise (FSX) at Namanga
11 – 14 June 2019 | Concept Note
Screenshot 2021-08-23 at 090813 Lesson Learned from a Large Cross-Border Field Simulation Exercise to Strengthen Emergency Preparedness in East Africa, 2019 DownloadLesson Learned from a Large Cross-Border Field Simulation Exercise to Strengthen Emergency Preparedness in East Africa, 2019
Published by Health Security | Volume 19, Number 4, 2021
Screenshot 2019-06-27 at 161418 Lessons for the Future – What East African experts learned from fighting the Ebola epidemic in West Africa DownloadLessons for the Future – What East African experts learned from fighting the Ebola epidemic in West Africa
Summary Conference Report | 13 December 2017
Screen Shot 2018-04-16 at 102316 Lessons for the Future: What East African experts learned  from fighting the Ebola Epidemic in West Africa DownloadLessons for the Future: What East African experts learned from fighting the Ebola Epidemic in West Africa
Conference Report | A regional conference with international participation held in Nairobi, Kenya | 6th to 8th November 2017
Screenshot 2019-10-08 at 173544 Lessons Learned from a Cross-Border Field Simulation Exercise between Kenya and Tanzania DownloadLessons Learned from a Cross-Border Field Simulation Exercise between Kenya and Tanzania
Namanga, 11th to 14th June 2019
mr4 Letter of Access to EAC-APIMF DownloadLetter of Access to EAC-APIMF
Annex VI
Screenshot 2021-08-23 at 164347 List of Medical Products Recommended for Registration through the EAC Joint Assessment Procedure DownloadList of Medical Products Recommended for Registration through the EAC Joint Assessment Procedure
EAC Medicines Regulatory Harmonization Programme
Screenshot 2022-04-20 at 104314 List of Medicinal Products recommended for Marketing Authorization through the EAC Joint Scientific Assessment Procedure DownloadList of Medicinal Products recommended for Marketing Authorization through the EAC Joint Scientific Assessment Procedure
April 2022
mr21 List of Standard Terms for Pharmaceutical Dosage Forms and Routes of Administration DownloadList of Standard Terms for Pharmaceutical Dosage Forms and Routes of Administration
PART VIII | EAC/TF-MED/MER/FD/TERMS/NR10
Screenshot 2019-09-16 at 164553 Logistics Management of Regional Outbreak Preparedness, Early Warning and Response DownloadLogistics Management of Regional Outbreak Preparedness, Early Warning and Response
Standard Operating Procedure: Integrated Disease Prevention and Control in the EAC
gmp2 Manufacture of Biological Products for Human Use DownloadManufacture of Biological Products for Human Use
Annex 2 | EAC/TF-MED/GMP/GDL/N1R0
gmp1 Manufacture of Sterile Medicinal Devices DownloadManufacture of Sterile Medicinal Devices
Annex 1 | EAC/TF-MED/GMP/GDL/N1R0
pl4 Ministerial Communique on Advocacy and Support for the Harmonization and Strengthening of Medicines Regulation in the EAC and the African Continent DownloadMinisterial Communique on Advocacy and Support for the Harmonization and Strengthening of Medicines Regulation in the EAC and the African Continent
October 2014
Screenshot 2022-08-19 at 125353 Mobile laboratories for SARS-CoV-2 diagnostics: what Europe could learn from the East African Community to assure trade in times of border closuresMobile laboratories for SARS-CoV-2 diagnostics: what Europe could learn from the East African Community to assure trade in times of border closures
Commentary
health2_0 1st International High Level Multi-Stakeholders Conference on promoting Pharmaceutical sector in EAC1st International High Level Multi-Stakeholders Conference on promoting Pharmaceutical sector in EAC
1st International High Level Multi-Stakeholders Conference on promoting Pharmaceutical sector in EAC | Presentations
PJ4 Optimizing the EAC's Medicines Regulatory Harmonization initiative in 2020-2022: A Roadmap for the Future DownloadOptimizing the EAC’s Medicines Regulatory Harmonization initiative in 2020-2022: A Roadmap for the Future
Published 12 August 2020
Screen Shot 2018-03-23 at 112124 Outcome of the Health Donor/Investors Roundtable DownloadOutcome of the Health Donor/Investors Roundtable
By: Hon. Sarah A. Opendi, Minister of State (Health), Uganda & Chair, EAC Sectoral Council on Health
egerton report  Pandemic Preparedness with a One Health (PPOH) Approach DownloadPandemic Preparedness with a One Health (PPOH) Approach
Report on Pilot of the short course
Screenshot 2022-02-14 at 125032 Panprep Project Media Monitoring Report  DownloadPanprep Project Media Monitoring Report
2021 Report
postfsxreport Post Exercise Report DownloadPost Exercise Report
Cross-Border Field Simulation Exercise Namanga One Stop Border Post
md6 Post Market Surveillance Annual Report Submission Form DownloadPost Market Surveillance Annual Report Submission Form
June 2020
pv4 Procedure for Submission of EAC Active Pharmaceutical Ingredient Master File (EAC-APIMF) DownloadProcedure for Submission of EAC Active Pharmaceutical Ingredient Master File (EAC-APIMF)
June 2020
mr6 Product Quality Review (PQR) Requirements for Generic Pharmaceutical Products DownloadProduct Quality Review (PQR) Requirements for Generic Pharmaceutical Products
Annex VIII
Screen Shot 2018-03-23 at 111212 Promoting private sector contribution towards achieving UHC and ending extreme poverty by2030 DownloadPromoting private sector contribution towards achieving UHC and ending extreme poverty by2030
By: Dr. Tim Evans, Senior Director of Health Nutrition and Population, World Bank
Screen Shot 2017-06-20 at 153849 Protocol on the Establishment of the East African Health and Research Commission (EAHRC) DownloadProtocol on the Establishment of the East African Health and Research Commission (EAHRC)
Protocol on the Establishment of the East African Health and Research Commission (EAHRC)
gmp3 Qualifications and Validation DownloadQualifications and Validation
Annex 3 | EAC/TF-MED/GMP/FD/GDL/N1R0
mr3 Quality Information Summary (QIS) DownloadQuality Information Summary (QIS)
Annex IV
mr5 Quality Overall Summary – Product Dossier (QOS- PD) DownloadQuality Overall Summary – Product Dossier (QOS- PD)
Annex VII
gmp8  Quality Risk Management (QRM) DownloadQuality Risk Management (QRM)
Annex 8 | EAC/TF-MED/GMP/FD/GDL/N1R0
Screenshot 2023-03-24 at 161920 Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening DownloadRegulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening
Published 16 March 2023
Screenshot 2019-09-16 at 164825 Reporting Emergencies and Activating EAC Regional Emergency Response DownloadReporting Emergencies and Activating EAC Regional Emergency Response
Standard Operating Procedure: Integrated Disease Prevention and Control in the EAC
md9 Requirements for Assessment and Authorization on In-Vitro Diagnostic Medical Devices  DownloadRequirements for Assessment and Authorization on In-Vitro Diagnostic Medical Devices
June 2020
mr16 Selection of a Comparator Product to be used in Establishing Interchangeability DownloadSelection of a Comparator Product to be used in Establishing Interchangeability
Annex IV | EAC/TF-MED/MER/FD/EQUIVALENCE/NR10
Screenshot 2022-02-04 at 092400 Severe Acute Respiratory Syndrome in East Africa 2021 DownloadSevere Acute Respiratory Syndrome in East Africa 2021
Book of Abstracts
scm-mrh Stakeholder’s Consultative Meeting on EAC Joint Regulatory Procedure and Sustainability Plan DownloadStakeholder’s Consultative Meeting on EAC Joint Regulatory Procedure and Sustainability Plan
Concept Note
scm-mrh-prog Stakeholder’s Consultative Meeting on EAC Joint Regulatory Procedure and Sustainability Plan DownloadStakeholder’s Consultative Meeting on EAC Joint Regulatory Procedure and Sustainability Plan
Provisional Programme
mr14 Submission of Active Finished Pharmaceutical Products (FPP) to the EAC DownloadSubmission of Active Finished Pharmaceutical Products (FPP) to the EAC
Invitation for Expression of Interest (EOI) | June 2020
pv4 Submission of Active Pharmaceutical Ingredient Master File (APIMF) to the EAC DownloadSubmission of Active Pharmaceutical Ingredient Master File (APIMF) to the EAC
Invitation for Expression of Interest (EOI) | July 2021
md10 Summary Technical Documentation (STED) for In-Vitro Diagnostic Medical Devises Dossier DownloadSummary Technical Documentation (STED) for In-Vitro Diagnostic Medical Devises Dossier
June 2020
Screenshot 2019-03-13 at 101354 Support to Pandemic Preparedness in the EAC Region DownloadSupport to Pandemic Preparedness in the EAC Region
Integrated Disease Prevention and Control in the EAC
Screenshot 2022-08-19 at 125751 The East African Community (EAC) mobile laboratory networks in Kenya, Burundi, Tanzania, Rwanda, Uganda, and South Sudan—from project implementation t DownloadThe East African Community (EAC) mobile laboratory networks in Kenya, Burundi, Tanzania, Rwanda, Uganda, and South Sudan—from project implementation t
Screen Shot 2018-04-13 at 100044 2nd EAC Regional Pharmaceutical Manufacturing Plan of Action 2017–2027 Download2nd EAC Regional Pharmaceutical Manufacturing Plan of Action 2017–2027
2nd EAC Regional Pharmaceutical Manufacturing Plan of Action 2017–2027
TypePlanTotal Downloads954
«12»1 of 2

Blog at WordPress.com.