1. EAST AFRICAN COMMUNITY MEDICINES REGULATORY HARMONIZATION (EAC-MRH) PROJECT PROGRESS NAIROB I - KENYA By: EAC - Secretariat

2. PRESENTATION OUTLINE
Overall EAC –MRH Goal
EAC – MRH 6- Objectives
EAC – MRH Progress
Benefits offered by EAC -MRH
Leasons Learnt
Way Forward

3. OVERALL EAC –MRH Goal
1. The East African Community MRH Programme was officially launched on 30th March, 2012, in Arusha, Tanzania.
2. Purpose: To improve access to safe, efficacious and good quality essential medicines for the treatment of conditions of public health importance
3. Goal: To have a harmonized and functioning medicines regulatory system within in accordance with national and internationally recognized policies and standards [WHO & ICH]
4. Founding Partners: EAC, BMGF, UK-DfID, WHO, AU- NEPAD, WHO, WB

4. EAC – MRH 6- Objectives
1. Objective 1 To implement an agreed common technical document for registration of Medicines in the EAC Partner States 2. Objective 2 To implement Integrated Information Management System for medicines registration in each of the EAC Partner States NMRAs which is linked in all Partner States and EAC Secretariat 3. Objective 3 To implement a quality management system in each of the EAC Partner States NMRAs 4. Objective 4 To build regional and national capacity to implement Medicines registration harmonization in the EAC

5. Cont’n
5. Objective 5 To create a platform for information sharing on the harmonized medicines registration system to key stakeholders at national and regional level 6. Objective 6 To develop and implement framework for mutual recognition based on Chapter 21, Article 118 of the East African Community Treaty

6. EAC – MRH Progress
Common Technical Document: Since Jan Official domestication of the EAC Harmonized Guidelines
Up to 5395 applications received in the region and 916 been registered
Integrated Information Management System: is being implemented in Pharmacy and Poisons Board and Tanzania Food and Drug Authority
IMS Progress: is at different levels at Department of Pharmacy and Medical Laboratories- Burundi, National Drugs Authority -Uganda , Ministry of Health Rwanda, and Zanzibar Food and Drugs Board
Quality Management System: at NMRAs- TFDA is ISO 9001:2015 Certified
PPB – Kenya, NDA Uganda, and ZFDB – URT are expected attain Certification by June 2016
6. Good Manufacturing Practice: About 10 Pharmaceutical Manufacturing plants have been inspected by the EAC – GMP Inspectors (in EAC -PS, India and Egypt
7. Jointly Partner States NMRAs – Experts have assessed 27 application, 4 products already registered

7. EAC – MRH Progress – Cont’n
Regional Pharmaceutical Policy, Mutual Recognition Framework and Information sharing development is on-going
Drafts are ready and currently under stakeholders consultations for inputs and consideration for approval
Capacity Building Programme
Twinning between NMRAs in capacity building exchanges and three sessions have been conducted in areas MER
QMS regional training of 35 lead auditors and over 60 in QMS requirements and procedures
MER trained over 30 Assessors
GMP basic and advanced over 40 have been trained
A number of staff have received training on the use and application of the IMS

8. Benefits offered by EAC -MRH
Benefits of Medicines Regulatory Harmonization
National governments
Medicines regulatory harmonizationefforts can effectively lead to the following;
quicker access to affordable, priority essential medicines of assured quality for patients,
improved public health outcomes;
more effective medicines control by the strengthened national drug regulatory authorities;
improved procurement practices for securing priority medicines
cost efficiency for governments

9. Cont’n Pharmaceutical Manufacturers
Quick aaccess to larger markets in the region
Easy to invest in pharmaceutical manufacturing in the region
More locally manufactured products registered
Joint Medicinal product dossier assessments, GMP inspections and electronic submissions – saves time and scarce resources
Industry responds to same one set of query questions from evaluated dossiers
No need to prepare for individual NMRA’s inspection

10. EAC –MRH IMPLEMENTATION STRENGTH
1. EAC Treaty: Chapter 21, Article 118 on Regional Cooperation on Health. One of the Key Policy Priority is Harmonization of Medicines Registration and Regulation
2. Four (4) established experts working group (EWG) of MER, GMP, QMS & IMS
3. Steering Committee for EAC-MRH
4. Streamlined process with oversight, decisions and recommendations making by the different EAC Policy Organs
EAC Technical Working Group for Medicines and Food Safety
EAC Sectoral Committee on Health
EAC Sectoral Council of Ministers of Health
EAC Council of Ministers
5. Strong partnership with AMRH- Partners WHO, BMGF, DfID, WB and NEPAD taking lead
6. Establishment of the Forum of Heads of National Medicines Regulatory Authorities - to fast track registration of jointly assessed products

11. Leasons Learnt
Regional collaboration and co-operation is very key in pushing forward effective medicines regulation, is working in East Africa
2. Involvement of key stakeholders ( industry, consumers and policy makers is crucial for ownership and sustaining the programme at national and regional level
3. Existence of structured NMRAs in Partner States is important to run the harmonization agenda
4. Enabling legal and regulatory framework in Partner States plays a big role in the harmonization process
5. Continued collaboration and corporation with key stakeholders is very important
- ICH- International Conference on Harmonization, - NMRAs- Medicines Regulatory Authority
- GCG –Global Cooperation Group , - NEPAD – New Partnership for African Development

12. Way Forward
Mobilization of the pharmaceutical Industry domestic and international to take advantage of EAC –MRH
Alignment of national and regional pharmaceutical policies and regulatory framework to ensure maximum benefits from regional integration, for medicines regulatory harmonization
Address other areas of concern: Pharmacovigilance, Post Marketing Resources, Clinical trials regulation and oversight
Develop Regional Essential Medicines List and Standard Treatment Guidelines among others
Continue strengthening Institutions and Collaboration among stakeholders

13. ONE PEOPLE ONE DESTINY thank YOU