HARMONIZATION OF
GMP INSPECTION IN THE
EAST AFRICAN COMMUNITY
WHO Technical Briefing Seminar
5th November 2014
Presented by:
Kate Kikule (Mrs.)
Technical Officer (Rotational)
World Health Organization
Geneva, Switzerland
7/28/2017
1
Presentation Outline
 Facts
about EAC
 Background to medicine
regulation harmonization in EAC
 EAC GMP TWG
 Achievements
 Challenges
 Plan for the future
7/28/2017
2
EAST AFRICAN COMMUNITY
7/28/2017
3
EAC Quick Facts
Area (including water):
1.82 million km2
Population:
143.5 million
GDP (current market price):
$110.3 billion
EAC Headquarters:
Arusha, Tanzania
EAC first established
1967
EAC dissolved
1977
EAC re-established
July 7, 2000
Rwanda and Burundi became
members of the EAC
July 1, 2007
Main languages:
English, Kiswahili, French
7/28/2017
4
Background to Harmonization in the EAC
Year
Activity
Outcome
1999 EAC Treaty
Cooperation among EAC States
2000 Directive of the EAC Council of
Ministers
Research, Policy and Health Systems
Working group tasked to draft common
Drug Policy and Harmonized drug
regulation procedures
2001 Meeting of Technical staff from NMRAs
in EAC
Developed guidelines and application forms
for registration of Veterinary Drugs
2005 EAC Customs Union
Common external tariffs on medicines
2005 African Drug Regulators Conference,
Addis Ababa
Recommendation to promote
harmonization using existing RECs
2005 Kampala meeting
Action plan for harmonization in the EAC
2006 Nairobi
7/28/2017
Formation
of TWGs
5
Background II
Setback to the 2006-2008 Action plan
◦ Slow progress of implementation
◦ Inadequate funding of TWGs
 However, the consortium of WHO, NEPAD, DFID
and GTZ, expressed their interest in supporting
RECs, (Johannesburg, Feb 2009) and called for
funding proposals from RECs

7/28/2017
6
EAC Medicine Regulation
harmonization project
Funded by Bill and Melinda Gates
Foundation
 Duration – 5 years
 Four(4) regional technical working groups
were established

◦ Medicine registration – Tanzania
◦ Good Manufacturing Practice Inspection –
Uganda
◦ Information Management Systems – Rwanda
◦ Quality Management Systems - Kenya
7/28/2017
7
EAC GMP TWG Composition
 The
technical working group is
composed of twelve members
drawn from the six NMRAs of the
Republics of Burundi, Kenya, Rwanda
, Uganda and The United Republic of
Tanzania (Mainland) and Tanzania
(Zanzibar)
7/28/2017
8
Aim of the harmonization
initiative

Harmonized legal framework for GMP,
guidelines and procedures for GMP
Inspection

Development of medicine regulatory curricula
and training materials, including e-learning

Improved regulatory systems for faster access
of quality medicines on to the EAC market
7/28/2017
9
Achievements:
Guidance Documents developed and
approved for use within the EAC


Manual for Good Manufacturing Practice Inspection
Guidelines for:
 GMP of medicinal products and related annexes
 preparation of site master file for pharmaceutical
manufacturing facilities
 Training and Qualifications of GMP Inspectors

Standard Operating Procedures for:

planning for GMP inspections
 preparing for a GMP inspection
 conducting a GMP inspection
 preparing and reviewing a good manufacturing practice
inspection report
 follow up on non-compliances after GMP inspection
 Joint GMP inspections
7/28/2017
10
Achievements II
Under the WHO PQ-EAC Inspection Collaboration
Procedure with EAC NMRAs:
 exchange of information including inspection schedules
through a secure website
 WHO support to training of GMP Inspectors through
training courses
 Inspectors from EAC Partner States NMRAs have
participated in joint inspections as either observers or
co-inspectors
 Inspectors have used the prequalification program as a
platform for capacity building at international level
through participation in inspections as observers
Inspectors from different NMRAs have participated in
joint inspections within the region when Partner States
NMRAs are inspecting facilities within their countries
7/28/2017
11
TFDA
NDA
ZFDA
KPPB
RWANDA
7/28/2017
12
Challenges
Lack
of mutually recognized legal frame work
encompassing all the Partner States reduces the speed at
which the TWGs are moving. Each Partner State has its
own laws and regulations that are independent
All
the Partner States NMRAs are at a different levels of
medicine regulation and as a result moving at the same
speed is still a challenge
7/28/2017
13
Plan for the future
Plan
for July 2014 to June 2015:
Continue with joint inspections among member
states
 twinning among the member states
 develop formal training program for GMP
Participate in development of a legal framework for
GMP
Continuous,
regular
joint inspections with other
international bodies, programs like the WHO pre-qualification
program and other well resourced NMRAs
Common
database and a platform for sharing information
which will guide regulatory decisions
7/28/2017
14
7/28/2017
15
Thank you
for listening
[email protected]
[email protected]
7/28/2017
16