NEWSLETTER
ISSUE 13
HIGHLIGHTS
SADC gears toward
launching their Medicines
Regulatory Harmonisation
Project
EAC held the first regional
consultation on an AU Model
Law on Regulation and
Harmonization of Medical
Products
NEPAD Agency designates
Regional Centres of Regulatory
Excellence (RCOREs) for
better regulatory capacity
development in Africa
The NEPAD Planning and Coordinating Agency designated in May 2014
fi rst regional RCOREs with the aim of increasing regulatory capacity development in Africa. RCOREs are institutions or partnership of institutions
with specific regulatory science expertise as well as training capacities.
As an initiative of the NEPAD African Regulatory Harmonisation (AMRH)
programme, the designation of RCOREs was inclusive, participatory and
followed clear and transparent procedures. Undertaking consultations with
key stakeholders and experts prior to the launch of the process was a very
starting point in order to get constructive comments, views and advices. The
selection process started with the call for applications of expression of interests in October 2013; which was followed by the assessment of applications
received. Approval and selection was based on eligibility criteria which were
stated in the call for bid and expression of interests.
Upcoming Events
To be designated as an RCORE, the following issues were taken into consideration: regulatory capability, training capacity, governance and management system, and infrastructure.
AMRH towards
implementing a Monitoring,
Evaluation, and Learning
(ME&L) Framework and
Impact Assessment Tool
The regulatory capacity entails the technical leadership and capability to
accomplish its assigned mission in at last one category of regulatory functions
identified in an outstanding manner. The training capacity implies that an
RCORE must have adequate technical personnel to undertake the regulatory functions and/ or training in one of the identified category.
NEPAD Agency AMRH
Programme eﬀorts in
Regulatory Curriculum
Development and
Fellowship Programmes
On the other hand, the governance and management system implies that the
institution or partners of institutions constituting an RCORE must have an
approved governance structure with proven governance and support structures. The infrastructure side means that the institution or partner of institutions must have required resources (fi nancial, administrative, and physical) to
perform its mandate or functions.
A total of ten (10) RECOREs were designated and are scattered on the African continent. The WHO Collaborating Centre for Advocacy and Training
in Pharmacovigilanance located in the University of Ghana Medical School
and the Pharmacy and Poisons Board (PPB) of Kenya were designated as
RECOREs in Pharmacovigilance. The Kilimanjaro School of Pharmacy;
St. Luke’s Foundation in Tanzania and the Centre for Drug Discovery, Development and Production (University of Ibadan) in Nigeria were designated
as RCOREs in training in core regulatory functions. The WHO Collaborating Centre for the Quality Assurance of Medicines (NWU - Potchefto next page
ISSUE 13
PAGE 2
from page 1
stroom Campus) in South Africa was
designated as an RCORE in Quality
Assurance and Quality Control of
medicines.
The Medicines Control Authority of
Zimbabwe (MCAZ)
was designated for medicine registration and
evaluation, Quality Assurance/Quality Control and clinical trials oversight. On the other hand, the National Drug Authority (NDA) in Uganda
was designated as an RCORE in licencing of the manufacture, import,
export, distribution and; inspection
and surveillance of manufacturers,
importers, wholesalers and dispensers
of medicines. The General Directorate of Pharmacy, Medicines and Laboratories together with the University of Ouagadougou in Burkina Faso
were designated as an RCORE in
clinical trials oversight. The Ghana-
ian Food and Drugs Authority (FDA)
was designated for medicine evaluation and registration and clinical trials oversight; and the Tanzania Food
and Drug Authority (TFDA) in partnership with the School of Pharmacy
Muhimbili University of Health and
Allied Sciences (MUHAS) were designated as an RCORE in medicine
evaluation and registration.
The role of RCOREs in the advancement of the public health sector in Africa is very crucial. The main reason
laying at the foundation of RCOREs
are mainly regulatory capacity challenges that African Regulatory Authorities and the pharmaceutical
industry were facing. RCOREs will
therefore have a greater role to play
by producing a competent regulatory
workforce. As an eﬀective medicines
regulation requires a regulatory science expertise, RCOREs will develop
a critical mass of regulatory expertise
in diﬀerent categories mainly through
the provision of academic and technical training in regulatory science.
Skills enhancement through handson training, twinning and exchange
programmes among National Regulatory Authorities (NMRAs); and
practical training though placement
in pharmaceutical industry and/ or
NMRAs are other methods RCOREs
will use to deliver their mandate and
functions.
The process of designation of
RCOREs would not have been successful without the support of the
AMRH partners and stakeholders.
A continued and committed partnership with NMRAs and the African
Union member States and external
partners will lead to the success of the
RCOREs and to further initiatives
directed towards the strengthening of
the public health on the African Continent.
SADC gears toward launching their Medicines
Regulatory Harmonisation Project
Meeting participants group photo
Mr Godfrey Kadewele (Malawi), Mr Joseph Mthetwa (SADC Secretariat)
and Mr Hitti Sillo (Tanzania) having a brief chat during a break
Mrs Chimwemwe Chamdimba,
NEPAD Senior Programme Oﬃcer
presenting the process undertaken in
developing the SADC-MRH Project
Following the February 2014 the consultation
meeting of African Medicines Regulatory Harmonisation (AMRH) Partners namely NEPAD
Agency, World Health Organisation and the
World Bank with SADC Secretariat and SADC
TROIKA Member States, the SADC Heads
of National Medicines Regulatory Authorities
(NMRAs) met in Gaborone, Botswana from 1618 June 2014. This meeting aimed to fi nalise the
draft project framework and work plan as well as
terms of reference (TORs) for the Project Steering Committee and Technical Working Groups
(TWGs) in preparation for submission to SADC
Policy organs for approval.
to next page
Mauritius and Mozambique representatives
ISSUE 13
from page 2
The SADC-Medicines Regulatory
Harmonization (MRH) Project will
help to improve Public Health by
achieving rapid and sustainable access to quality, safe and aﬀordable essential medicines through a harmonised registration mechanism. This
will lead to the reduction of the time
taken to register essential medicines
for the treatment of diseases.
Mr Josepth Mthetwa, SADC Senior
Programme Oﬃcer for Health and
Pharmaceuticals said that the success
of this project, will not be dependent
on the SADC Secretariat but rather
the SADC Member States and the
Member States reaﬃ rmed their commitment to launch and commence
with the implementation of the project.
The meeting noted that although the
SADC-MRH project proposal was
validated by the NMRAs, Industry
and AMRH Partners in 2011, some of
the activities that were planned then,
are currently being implemented even
before the SADC-MRH project is officially launched in November 2014.
The activities being carried out include such by Member States include
updating the technical guidelines for
registration of medicines and fi nalising the common technical document
(CTD) format through the support
of Southern African Regional Programme on Access to Medicines and
Diagnostics (SARPAM).
The project will be managed by the
Project Steering Committee and their
overall objective will be to ensure implementation of agreed harmonised
requirements for registration of medicines, that an integrated Information
Management system is in place and
is being shared, a certified Quality
Management System in all member
states and to provide a framework
for mutual recognition of regulatory
decision emitted by other member
states. The outcome of this meeting
laid the foundation for initial steps
in the implementation of the SADCMRH project which will be oﬃcially
endorsed by the Council of Ministers
in November 2014.
PAGE 3
AMRH towards implementing
a Monitoring, Evaluation, and
Learning (ME&L) Framework and
Impact Assessment Tool
AMRH and EAC-MRH discussing the ME&L framework
A M&E Framework and Impact Assessment Tool was developed within
the African Medicines Regulatory
Harmonisation (AMRH) for appropriate tracking of the progress of implementation of the program in Africa, and evaluating impact made by
the programme.
For a successful implementation of
AMRH, there is a need for an effective Monitoring, Evaluation and
Learning (ME&L) system that will
enable collection, analysis and reporting of relevant data to support
informed policy processes. Monitoring and Evaluation have been documented as a key tool for the success
of development programmes and
projects. Monitoring and evaluation
are important for two main reasons.
The fi rst reason is that they enable
learning and development. Monitoring and evaluating help organisations and programs/projects to assess
how well they are doing and help to
do better. It is about asking what has
happened and why – what is and what
is not working. Evaluation is used to
learn more about an organisation and
programme’s activities, and then using what has been learnt. The second
reason is accountability. An organisation, a programme or project has to
show others that it is eﬀective. It is obvious that donors and other sponsors
want to know whether a programme
or a project has spent its money in the
right way. In other words, monitoring
and evaluation provide proof of what
has been achieved.
AMRH have therefore developed a
ME&L framework to be implemented initially in EAC partner states.
It should be reminded that AMRH
works in partnership with RECs; and
East African Community is leading
in implementing MRH. The ME&L
will therefore enable AMRH and
EAC to communicate results of the
various regulatory interventions. It
will also help the programme to assess
whether funds allocated to it are producing the intended results and that
the programme is being implemented
as planned.
To operationalize that framework, a
tool for collection was developed. It
comprises key indicators which were
drawn from the programme. The
data collection tool will be sent out to
National Medicines Regulatory Oﬃcers who will be in charge of collecting data at the country level and to
the EAC Secretariat which will provide information related to regional
activities. Data collected in 2010 prior to the launch of implementation of
AMRH will be used as baseline data.
AMRH held discussions with EAC
Secretariat about that ME&L
framework in (May) and June 2014.
Prominently, a training workshop
of NMROs on how they will be collecting data was held in Bujumbura,
Burundi in August 2014. The implementation of the AMRH ME&L is
promising and it is hoped that it will
generate intended results and hence
implementation of AMRH will be
successful and sustainable.
ISSUE 13
PAGE 4
NEPAD Agency AMRH Programme eﬀorts in Regulatory
Curriculum Development and Fellowship Programmes
The AMRH Programme convened
the second meeting of the Technical
Working Group (TWG) on Regulatory Capacity Development (RCD)
sub-committee on Curriculum Development and Fellowship Programme in
Cape Town on 1-2 September 2014.
The main objective of the AMRH
TWG RCD Sub-Committee on Curriculum Development & Fellowship
Programme is to provide technical
advice to NEPAD Agency AMRH
Programme, TWG Regulatory Capacity Development and the AMRH
Advisory Committee on areas for intervention in regulatory curriculum
development in order to strengthen
medicines regulatory capacities and
systems in Africa.
The specific objectives of TWG RCD
Sub-Committee on Curriculum Development & Fellowship Programme
are:
• To facilitate research and knowledge management on regulatory science curricula in Africa
• To facilitate regulatory science curricula reforms in keeping with new
developments in the regulatory affairs
field
• To establish collaborative partnerships in regulatory science curricula development between National
Medicines Regulatory Authorities
(NMRAs), academia and industry
• Advance the discipline of regulatory science in support of the African
Medicines Regulatory Harmonization
(AMRH) initiative
• To bridge the regulatory divide
between the developed and developing countries through coordination of
twining programmes among NMRAs
in collaboration with academic institutions
• To review qualifications and certification schemes for regulatory training
programmes in Africa at different levels: diploma, graduate and post-graduate and short-term courses on offer;
and
• Review a strategy for curricula
development and Fellowship programmes.
TWG-RCD Subcommittee CD&FP Meeting Participants: Seated:
L-R: Ms. Gugu Mahlangu (MCAZ, Zimbabwe), Ms. Margareth Ndomondo-Sigonda (NEPAD, South Africa)
Standing: L-R: Prof. Henry Leng (MCC/UWC, South Africa), Ms.
Nthabiseng Legodi (NEPAD, South Africa), Mr. Paul Tanui (NEPAD, South Africa), Prof. Alex Dodoo (WHO Collaborating Centre
for Advocacy and Training in Pharmacovigilance, Ghana)
The meeting considered the following:
• Reviewed the progress on CD&FP
March 2014 Action Plan. The March
Action Plan mandated the subcommittee to develop harmonized and
standardized Regulatory Science
Curricula for Regional Centres of
Regulatory Excellence (RCOREs);
standardize operations, designate and
administer RCOREs; and to develop
well defined procedures for administering NEPAD Regulatory Science
Fellowship Programme.
• Reviewed the Draft Guide for Regional Centres of Regulatory Excellence (RCOREs)
• Reviewed the Draft Guide for Africa Medicines Regulatory Professionals
Fellowship Programme
• Reviewed the Body of Knowledge
for the Africa Medicines Regulatory
Professionals Fellowship Programme
The outcome and draft documents developed by the sub-committee will be
discussed and approved by the Technical Working Group (TWG) Regulatory Capacity Development (RCD) and
the AMRH Advisory Committee.
ISSUE 13
PAGE 5
EAC held the first regional
consultation on an AU Model Law
on Regulation and Harmonization
of Medical Products
The High Table shortly before opening of the consultations
The East African Community (EAC)
opened a series of consultations on a
Model Law intended to regulate and
harmonise medical products in Africa before that the Law is promulgated
by the African Union. That consultation was held in the Tanzanian Capital City, Dar es Salaam on 31st July,
2014.
The consultation was promising and
was attended by very important and
high level delegates from the EAC
member counties, pharmaceutical industry, civil society, AMRH international partners and stakeholders (The
World Bank, WHO, U.S. Pharmacopeia), the African Union Commission
(AUC), the Pan African Parliament
(PAP), and NEPAD Agency. All delegates who attended the consultation
showed interest in the Model Law,
constructively contributed to the process; and promised continued support
and commitment towards the fi nalisation of the Law.
The Model Law on medical products
regulation and harmonisation will
serve as a blueprint to African countries to establish (for those who do not
have or revise their policy and legal
framework on regulation of medical
products. The Model Law will also
serve as a framework for harmonisation of the legal systems with other
African countries in order to increase
eﬃciency and reduce costs in regu-
lations of pharmaceutical products.
When giving his opening remarks,
Professor Aggrey Ambali, Head and
Advisor of the NEPAD Science and
Technology Innovations Hub emphasised that the majority of Africa
Countries do not have or have weak
and inappropriate legal framework
to regulate medical products; and
therefore reminded participants the
importance of the Law. In addition, a
WHO-AFRO report states development of comprehensive legal basis is
a condition sine qua non for countries
to have better regulation of medical
products.
The consultation meeting had three
main objectives. The fi rst objective
was to increase public awareness of
the AU Model Law on regulation and
harmonisation of medical products.
The second objective
was to elicit comments
on the contents of the
model law; and the
third was to generate
stakeholder buy-in in
the Model Law development and implementation. NEPAD
Agency will hold consultations on the same
Model Law in other
remaining Regional
Economic Communities (RECs) to
make sure that the process is inclusive and all member countries provide
comments. Next targeted regions for
consultations on the Model Law are
West Africa, Central Africa, Northern Africa, and Southern Africa.
Consultations on the Model Law on
regulation and harmonisation of medical product constitute one among key
steps required. The initial undertaking was the elaboration of zero draft
Model Law after holding consultations meetings with experts and other
identified key persons and institutions.
Consultations meetings were held between February and April 2012 and
were aimed at analysing existing
medicines legislations and regulatory
harmonisations guidelines; and to undertake optional analysis to analyse
diﬀerent practical options available.
The second step was the validation of
the draft Model Law through a workshop of experts. A Technical Working
Group (TWG) composed of experts
from all RECs including legal experts
and regulators, PAP, AUC, NEPAD
Agency, WHO, and UNAIDs was
made and has been holding meetings
since August 2013. The draft of Model Law was also examined three times
by the Pan African Parliament Committee on Health Labour and Social
Aﬀairs (CHLSA) in August and September 2013; and in March 2014.
The actual consultation meetings are
part of a third step which is the meeting of governments and legal experts
to get comments which have to be incorporated in the draft of the Model
Law by the TWIG. After regional
consultations, holding meetings with
Mrs. Margaret N.Sigonda having a word with Mr Hiiti
B. Sillo, D.G. of the Tanzania Food and Drugs Authority
(TFDA) and Dr Fred Siyoi, Deputy Registrar of Kenya
Pharmacy and Poisons Board.
ISSUE 13
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from page 5
AU Ministers of health, Ministers of
Justice/Attorneys, and submission of
the Model Law to AU Policy Organs
will follow before domestication by
AU Member States.
AMRH seeks to improve public
health by increasing access to good
quality, safe and eﬀective medicines.
The Model Law on regulation and
harmonization of medical products is
a key endeavour to the realization of
that end.
Group Photo of all Participants with the Guest of Honour
UPCOMING
EVENTS
November 2014:
USP-CePAT Biennial Awards in Global Health & Advisory Group Meeting
- Accra, Ghana, 8-9 November
AMRH Stakeholders Consultation meeting on Model Law on Medical Products Regulation and
Harmonization in Africa
- Harare, Zimbabwe, 18-19 November
Meeting of the Task Force for establishment of African Medicines Agency
- 25-26 November
African Society for Laboratory Medicine (ASLM) 3rd African Regulatory Forum on Medical Diagnosis
December:
Launch of the 2nd Programme of the European & Developing Countries Clinical Trials Partnerships
(EDCTP2)
- Cape Town, South Africa 1-3 December
ISSUE 13
PAGE 7
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