East African community (EAC committee organization) 83.pptx

East African Community (EAC Committee Organization)

1. East African community (EAC committee organization, structure, role, and function) Presented By: Bhavesh Thorat Guide By: DR. P.P. Nerkar Sir (HOD) Department Of Regulatory Affairs R.C.Patel Institute Of Pharmacy, Shirpur 1

2. Content: Introduction EAC Organs EAC Medicines Regulatory Guidelines Medicines Regulation In East African Community Medicines Evaluation and Registrations EAC Structure Vaccines, Biotherapeutics and Variations Good Manufacturing Practice Pharmacovigilance National Regulatory Authorities East African Health Research Commission EAC Joint Good Manufacturing Practice Inspections EAC Joint GMP Inspection Chart EAC Committee Organization Role EAC Committee Organization functions Reference 2

3. Introduction: The East African Community (EAC) is a regional intergovernmental organization of seven (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. The EAC aims at widening and deepening co-operation among the partner and other regional economic communities in, among others, political, economic and social fields for their mutual benefit. The Treaty for Establishment of the east African community was signed on 30th November 1999 and entered into force on 7th July 2000 3

4. The East African Community (EAC): is an is an intergovernmental organization composed of six countries in the African Great lakes region in eastern Africa It includes: Burundi Kenya Rwanda South Sudan Tanzania Uganda 4

5. EAC Organs: The main organs of the EAC are Summit Council of ministers Co-ordinating committee Sectoral committees East African court of justice East African legislative assembly Secretariat 5

6. The Community Flag 6

7. The Community Emblem (Logo) 7

8. Eac medicines regulatory guidelines: The EAC-MRH programme has developed guidelines for medicines registration, GMP inspections, pharmacovigilance, post marketing surveillance, medical devices, clinical trial control and policy frameworks. The Ministerial Communique On Advocacy and Support for the Harmonization and Strengthening of Medicines Regulation In the East African Community Partner States and the African Continent 8

9. Medicines Regulation in the East African Community: The regulation of health technologies is a critical component of every country’s public health system and ensures that high-quality vaccines, devices, diagnostics, and drugs reach the people who need them most. Medicines regulation, however, differs from country to country, which can result in delays for researchers and manufacturers who must navigate multiple regulatory systems to register the same health technology across countries. 9

10. Continue……. The East African Community (EAC) has demonstrated commitment to streamline medicines regulation and build regulatory capacity across partner states; it is one of the first RECs in Africa to develop and implement harmonization programs. Through the EAC Medicines Regulatory Harmonization (EAC MRH) initiative and other regional strategies, the EAC aims to decrease the amount of time to register essential medicines to treat priority diseases and reduce duplication of efforts through mutual recognition of decisions made by partner states’ national regulatory authorities (NRAs). 10

11. Medicines evaluation and registration: Compendium Of Guidelines for Marketing Authorization Of Human Products: Part Ⅰ : Guideline Application Quality Information Summary (QIS) Authorization to access Certificate of Suitability (CEP) Letter of Access to EAC-APIMF Quality Overall Summary- Product Dossier (QOS-PD) 11

12. Continue……. Parts Ⅱ and Part Ⅲ: Parts Ⅱ: EAC Guidelines on Stability Testing Requirements for Active Pharmaceutical Ingredients (APIs) and Finished Pharmaceutical Products (FPPs) Part Ⅲ: EAC Guidelines on Therapeutic Equivalence: Annex Ⅰ : Dissolution Testing and similarity of Dissolution Profiles Annex II: Bioequivalence Study Requirements for Different Dosage Forms Annex III: Biopharmaceutics Classification System (BCS) Based Biowaiver Biowaiver Application Form Annex IV: Selection of a Comparator Product to be used in Establishing Interchangeability Annex V: Bioequivalence Trial Information (BTIF) 12

13. Continue……. Parts IV to XI: Part IV: EAC Guidelines on Format and Content of Summary of Product Characteristics for Pharmaceutical Products Part V: EAC Guidelines on Format and Content of Labels For Pharmaceutical Products Part VI: EAC Guidelines on Format and Content of Package Inserts for Pharmaceutical Products Part VII: EAC Common Glossary of Terms Used in Medicines Registration Part VIII: List of Standard Terms for Pharmaceutical Dosage Forms and Routes of Administration Part IX: EAC Guidelines on Registration of Fixed Dose Combination Pharmaceutical Products 13

14. Continue……. Part X: EAC Guidelines on Procedural Aspects for Applications for Marketing Authorization of Pharmaceutical Products Part XI: EAC Guidelines on Naming of Medicinal Products Part XII Part XII: EAC Procedure on Evaluation of Quality of Active Pharmaceutical Ingredient 14

15. Continue……. Guideline for Abridged Procedure for the EAC Joint Assessment and Accelerated National Registration (by the EAC Partner State) of Pharmaceutical Products Approved by Stringent Regulatory Authorities and the World Health Organization -Prequalification Program (WHO PQ) Guidelines for Active Pharmaceutical Ingredient Master File Procedure Expression of Interest for Submission of Active Pharmaceutical Ingredient Master File (APIMF) Procedure Procedure on Submission of EAC – Active Pharmaceutical Ingredient Master File (EAC-APIMF) Application Form & Checklist for EAC-APIMF Cover Letter for EAC-APIMF 15

16. EAC Structure: 16

17. Vaccines, Biotherapeutics and Variations: Guidelines for Submission of Documentation for Registration of Biotherapeutic Products Application Form for Registration of Biotherapeutics and Similar Biotherapeutic Products Guidelines on Submission of Documentation for Registration of Human Vaccines Application Form for Registration of Human Vaccines Guidelines for Submission of Application for COVID-19 Vaccines AVAREF Guidelines WHO Guidelines 17

18. Good Manufacturing Practices: Basic Requirements for Implementation of Good Manufacturing Practices: Annex 1: Manufacture of Sterile Medicinal Products Annex 2: Manufacture of Biological Products for Human Use Annex 3: Qualifications and Validation Annex 4: Computerized Systems Annex 5: Water for Pharmaceutical Use Annex 6: Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms Annex 7: Authorized Persons Annex 8: Quality Risk Management (QRM) Annex 9: Active Pharmaceutical Ingredients Annex 10: Waste Management for Medicinal Product Manufacturers 18

19. Pharmacovigilance: Adverse Drug Reaction (ADR)/ Adverse Event Following Immunization (AEFI) Form Patient Adverse Drug Reactions Reporting Form Medical Devices Adverse Event/Incident Reporting Form Product Quality Reporting Form Patient Adverse Drug Reaction (ADR) Alert Card Format and Content of the Protocol of Non- Interventional Post-Authorization Safety studies Format of the Pass Final Study Report Methodological Aspects of Signal Detection from Spontaneous Reports of Suspected Adverse Reactions Format and Layout of Pharmacovigilance System Master File (PSMF) Pharmacovigilance Methods 19

20. National regulatory authorities: In most countries, legislation gives national governments the mandate to regulate medical products and research within their territory, through national regulatory authorities (NRAs). NRAs are responsible for ensuring the safety, efficacy, and quality of health technologies; they may also regulate clinical trials, manufacturing, and marketing of medical products. The comprehensiveness of regulatory legislation—and therefore the strength of NRAs—varies from country to country 20

21. EAST AFRICAN HEALTH RESEARCH COMMISSION: To support joint health research, the EAC developed the Protocol on the Establishment of the East African Health Research Commission (EAHRC), which created a regional body responsible for the coordination of health-related research. The EAHRC promotes collaborative research and development (R&D) programs; provides standardized research protocols, guidelines, and proposals; strengthens research capacity; and establishes quality assurance measures for health R&D. region. Finally, the EAHRC facilitates the development of evidence based, regional health policies and implementation within partner states. 21

22. Continue……. Partnership for Africa’s Development (NEPAD), Pan African Parliament (PA), and African Union Commission (AUC)—in Collaboration with WHO, the World Bank, the Bill & Melinda Gates Foundation, and the United Kingdom’s Department International Development—to increase access to health technologies through regulatory harmonization and to support Regional initiatives aimed at aligning medicines regulation. The Pharmaceutical Manufacturing Plan for Africa (PMPA), endorsed by the African Union in 2007, aims to strengthen Pharmaceutical manufacturers on the continent to produce high-quality, affordable medicines. A robust local pharmaceutical 22

23. EAC Joint Good Manufacturing Practice Inspections: Initiation of EAC joint GMP is through three mechanisms; • An official request from a manufacturer; • A joint interest of at least two EAC Partner States NMRAs • A joint procedure in the framework of a multiple application for marketing authorization to more than one NMRAs 23

24. EAC Joint GMP Inspections chart: 24

25. EAC Committee Organization Role: The mission of the Community is to widen and deepen economic, political, social and cultural integration in order to improve the quality of life of the people of East African people provides Health care facilities safety of the Drug and Medicinals products Provides rules regulations of drug registration process in East African Community. Providing the CTD Submission guidelines and process 25

26. East African community organization functions: Infrastructure Development. Access to affordable and efficient transport, energy, and communication for increased regional Competitiveness. Agriculture, Food Security and Rural Development. ... Industrialization. ... Natural Resources & Environment Management. ... Tourism, Trade & Services Development. ... Human Capital Development. Health Care Facilities 26

27. Reference: East African Community: https://www.eac.int/overview Testbook : https://testbook.com/east-african-community- Faster Captital : https://fastercapital.com/content/EAC--East-African-Community--Fostering-Regional-Integration-in-East-Africa.html 27

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