1. Harmonization for Patient Centered Universal Health Coverage
Kenya Association of
Pharmaceutical Industry
Harmonization for Patient Centered Universal Health Coverage
John M. Mwangi
KAPI, ARN (IFPMA)
IAPO Conference, Entebbe Uganda
04th July 2017

2. Introduction
Executive Committee Member and Ag. Executive Secretary Kenya Association of Pharmaceutical Industry – KAPI
Co-Chair Africa Regulatory Network - ARN (Adhoc IFPMA RPTS committee) & ARN EAC Subregion Co-Lead
Head, Regulatory Affairs, Bayer East & West Central Africa

3. Industry Perspective Industry Challenges
Requirements and procedural challenges tend to hamper timely regulatory approvals impacting negatively on medicines access in many African countries
Regulations & Interpretations
GMP Inspections
Lifecycle management variability
Industry
Review Timelines
Dossier Content

4. Highlight of key perspectives in relation to the ongoing harmonisation process
Harmonization of regulatory requirements is central to efficient utilization of limited resources
Focus on value adding activities, minimize administrative hurdles
Evidence based, scientific regulatory decisions
Work sharing, synergies and collaboration space for best resource utilization, overall cost reduction to the healthcare system

5. What does harmonization mean for African patients?
Fast access to new innovative Health Technologies & Products
Reliable, sustainable Supply Chain
Predictable medicines availability
Integrated Scientific Knowhow among HealthCare Providers
High quality, safe medicines
Market Control, reduced substandard products
Local / regional manufacture for essential products

6. What is needed for AMA to work in a transparent, accountable and effective way?
Early and All inclusive approach, from regulators, donors, patients, payers, industry
Exploit synergies to enhance the capacity and efficiency of regulatory systems
Collaboration & information sharing to reduce redundancy and optimize the use of resources
Information Management System & Internal Quality Management System
Political goodwill

7. Thank you

8. Potential Questions from Audience / Moderator
In what way would you say patients’ communities would benefit from a well-functioning, transparent and accountable AMA?
How do you think patient groups, advocates, and representatives could be meaningfully involved in AMA’s work?
Stakeholders forum
Policy formulation
Product development
Political goodwill
Reimbursement
Essential medicines list
What do you expect the key differences will be between AMA and more established structures around the world (FDA, EMA), especially in terms of patient involvement and engagement?
What does harmonisation mean to you, from the angle of the organisation/sector you are representing?