Introduction and Background:
Funded by the U.S. Agency for International Development (USAID), the Medicines,
Technologies,
and Pharmaceutical Services (MTaPS) program implemented by Management
Sciences for Health provides pharmaceutical system strengthening
assistance for sustained improvements in health system performance and
to advance USAID’s goals of preventing child and maternal deaths,
controlling the HIV/AIDS epidemic, and combating infectious disease
threats, as well as expanding essential health coverage.
The
goal of the global, five-year (2018–2023) program is to enable low- and
middle-income countries to strengthen their pharmaceutical systems to
ensure sustainable access to and appropriate use of safe, effective,
quality-assured, and affordable essential medicines and medicine-related
pharmaceutical services. To achieve this goal, the MTAPS program has
the following objectives:
- pharmaceutical sector governance strengthened
- institutional
and human resource capacity for pharmaceutical management and services
increased, including regulation of medical products
- availability and use of pharmaceutical information for decision making increased and global learning agenda advanced
- pharmaceutical sector financing, including resource allocation and use, optimized
- pharmaceutical
services, including product availability and patient-centered
care to achieve desired health outcomes, improved
The
goal of MTaPS in Tanzania is to strengthen the country’s pharmaceutical
system to ensure sustainable access to and appropriate use of safe,
effective, quality-assured, and affordable essential medicines,
including ARVs, health technologies, and related pharmaceutical
services. A stronger pharmaceutical system in Tanzania will enable
achievement of global goals, including controlling the HIV/AIDS and TB
epidemics, preventing child and maternal deaths, combating other
infectious disease threats, and expanding access to essential medical
products in the journey toward achieving universal health coverage in
the country.
The Tanzania Medicines and Medical Devices
Agency (TMDA) is the national regulatory authority (NRA) in Tanzania.
It is an executive agency under the MOH responsible for regulating the
quality, safety, and effectiveness of medicines, medical devices, and
diagnostics. Its core functions are prescribed in Section 5 of the
Tanzania Medicines and Medical Devices Act, Cap 219, i.e., the
regulation of all matters relating to quality, safety, and efficacy of
human and veterinary medicines, herbal medicines, medical devices, and
diagnostics; the regulation of importation, manufacturing, labeling,
marking or identification, storage, promotion, sale, and distribution of
same; and the monitoring and analysis of existing and new adverse
events, interactions, and information about PV of products; and acting
upon said analysis
Regulatory
systems play a key role in ensuring the quality, safety, and efficacy
of medical products. The TMDA has attained WHO maturity level 3 (ML 3)
status for setting up a stable, well-functioning, and integrated
medicine/vaccine regulatory system, as benchmarked against the World
Health Organization (WHO) Global Benchmarking Tool (GBT) in 2018. It has
also established mobile and patient reporting systems for safety
monitoring of medicines.
The Medical Stores Department (MSD) is an
autonomous department under the MOH responsible for developing,
maintaining, and managing an efficient and cost-effective system of
procurement, storage, and distribution of approved medicines and medical
supplies required for use by public health services.
MTaPS
is therefore seeking a consultant to provide technical assistance to
support medicines registration, medical products importation procedures
and pharmacovigilance to achieve the goal of strengthening regulatory
systems in the Republic of Tanzania.
Supervision and
reporting responsibility: The consultant will be supervised by, and
report to the Principal Technical Advisor-Pharmacovigilance (PV) Lead.
The consultant will liaise with the Country Project Director for
Tanzania; the Principal Technical Advisor-Pharmaceutical Regulatory
Systems (PTA-PRS), MTaPS headquarters and regional technical staff, and
work in collaboration with the national regulatory authority and
relevant government departments.
A: Description of Services to be provided
Based on the background information provided by MTaPS, the consultant is expected to provide
technical
assistance by undertaking interventions in medicines registration,
medical products importation procedures and pharmacovigilance that will
strengthen regulatory systems, contributing to access to quality assured
medical products.
Specifically, the consultant will undertake the following activities:
1)
Activity 1.1.1: Conduct a process improvement mapping for registration
and importation of antiretroviral medicines (ARVs), including
dolutegravir (DTG), for the public sector (LOE 20 Days)
a. Develop an implementation plan for this activity with clear tasks and timelines for reaching process improvement milestones
b.
Liaise with the MTaPS Tanzania Country office to initiate meetings
with the National Regulatory Authority, TMDA, and MSD, and plan for
collection of information and implementation of the activity
c.
Develop a checklist/questionnaire for data collection on the sequence
of activities to register and import ARVs, including DTG, for public
sector distribution and use
d. Administer the questionnaire to relevant entities including MSD, TMDA
e. Prepare draft report on the findings of the process mapping including considerations for process improvements
f. Facilitate a one-day virtual workshop to validate the findings
g.
Finalize the report on process mapping improvement for registration
and importation of ARVs, including DTG, for the public sector.
2) Activity 1.1.2: Sustain the capacity of TMDA to assess quality, safety, and efficacy of ARVs (LOE 15 days)
a.
Develop an implementation plan for this activity with clear tasks and
timelines for reaching the capacity milestones and share it with the
PTA-PRS
b. Liaise with MTaPS Tanzania Country office to initiate
meetings with the National Regulatory Authority, TMDA, and plan for
delivery of virtual/in-person course to conduct capacity building on
comprehensive assessment of quality, safety, and efficacy of ARV
applications for registration. The capacity building should impart
knowledge and transfer skills to TMDA assessors in basic dossier
assessment of ARV product dossiers for the new medicine evaluators (new
staff, interns, and externals); and training to current medicine
evaluators on specialized areas, such as assessing bioequivalence
studies and active pharmaceutical ingredients, focusing on ARVs
c. Liaise with the appropriate academic institution for collaboration while implementing the capacity building workshop
d.
Prepare materials for delivery of a 5-day capacity building course on
evaluation and registration of medicines, covering training of new
assessors and refresher training for existent assessors
e. Organize and facilitate conduct of an in-person capacity building workshop on assessment of product dossiers for medicines
f. Prepare Report on capacity building workshop on product registration for medicines for regulators in Tanzania
g.
Organize and facilitate conduct of a product dossier evaluation
retreat for 5 days for the assessors to apply the knowledge and gain
hands-on experience in evaluating products, specifically medicines used
to manage HIV/AIDS
h. Prepare Report on product dossier evaluation retreat and number of product files for managing ARVs evaluated.
3)
Activity 2.1.1: Strengthen existing passive medicine safety
surveillance system for pediatric medicines used in national HIV program
(LOE 20 days)
a. In collaboration with relevant
TMDA and MTaPS staff, plan and set up a pediatric sub-committee as part
of the national safety advisory committee to evaluate adverse drug
reaction (ADR) reports on pediatric DTG and other pediatric ARVs in the
country
i. Undertake review of the terms of reference of current
national safety advisory committee and revise it for setting up the
pediatric sub-committee as necessary
ii. Establish a governance
structure for the pediatric sub-committee with clear deliverables for
enhancing the safety of pediatric DTG and ARVs in general
iii. Support inauguration of the committee members and at least one meeting of the committee.
b.
In collaboration with WHO, relevant industry experts, and MTaPS staff,
plan, execute and monitor capacity building of TMDA staff on evaluating
manufacturers’ risk management plans (RMPs) and periodic safety update
reports (PSURs) for pediatric drug formulations as part of a system-wide
sustainable capacity-building effort
i. Review or develop training materials
ii. Undertake training of staff including hands-on practice iii. Generate a report of the training.
c.
Work with TMDA and relevant stakeholders including but not limited to
public health programs, hospitals, and reporters to strengthen the
existing system for providing constructive feedback to stakeholders that
report ADRs. This will entail reviewing the current feedback mechanism
and identifying implementation gaps, including disincentives for
reporting
i. Review current feedback mechanism available at TMDA and identify implementation gaps
ii. Develop a revised stakeholder feedback framework and mechanism
d.
Develop a proposal for a follow-on activity that identifies and tests
different strategies for improving reporting with a view to finding the
most appropriate and context relevant strategy to improve ADR reporting
in Tanzania.
Total LOE: 55 days
B: Deliverables/Milestones
1) Implementation plan for Activity 1.1.1 with clear tasks and timelines for reaching the process improvement milestones
2) Draft report on the findings of the process mapping including considerations for process improvements
3) Report on process improvement mapping for registration and importation of ARVs, including DTG, for the public sector
4) Implementation plan for Activity 1.1.2 with clear tasks and timelines for reaching the capacity milestones
5) Materials for delivery of a virtual 5-day capacity building course on evaluation and registration of medicines
6) Report on virtual capacity building on medicines registration for regulators in Tanzania
7) Report on product dossier evaluation retreat and number of product files for managing ARVs evaluated
8) Terms of reference for a pediatric advisory sub-committee, including governance structure
9) Results of DTG and other pediatric ARVs ADR review
10) Report of training for TMDA staff on review of RMPs and PSURs for pediatric ARVs
11) Proposal for follow-on activity on strategies to improve reporting of ADRs.
C: Delivery Schedule/Milestones
Activity
1.1.1: Conduct a process improvement mapping for registration and
importation of ARVs, including DTG, for the public sector
1)
Deliverable: Activity Implementation plan with clear tasks and
timelines for reaching process improvement milestones (15 June 2021)
2) Draft report on the findings of the process mapping including considerations for process improvement (30 June 2021)
3)
Final Report on process improvement mapping for registration and
importation of ARVs, including DTG, for the public sector (25 July 2021)
Activity 1.1.2: Sustain the capacity of TMDA to assess quality, safety, and efficacy of ARVs
4) Activity implementation plan with clear tasks and timelines for reaching capacity milestones (15 June 2021)
5)
Materials for delivery of a virtual 5-day capacity building course on
evaluation and registration of medicines (30 June 2021)
6) Report on capacity building on medicines registration for regulators in Tanzania (31 July 2021)
7) Report on product dossier evaluation retreat and number of product files for managing ARVs evaluated (31 August 2021)
Activity
2.1.1: Strengthen existing passive medicine safety surveillance system
for pediatric medicines used in national HIV program
8) Terms of reference for a pediatric advisory sub-committee, including governance structure (30 June 2021)
9) Results of DTG and other pediatric ARVs ADR review (20 September 2021)
10) Report of training for TMDA staff on review of RMPs and PSURs for pediatric ARVs (31 August 2021)
11) Proposal for follow-on activity on strategies to improve reporting of ADRs (31 July 2021)
D: Authorized Travel (if applicable)
☒
MSH hereby authorizes Consultant to travel in connection with providing
the Services in accordance with the SOW as described below:
Within Tanzania
Consultant qualification requirements:
- First degree in Pharmacy or Medicine
- Advanced degree in Medicine, Pharmaceutical sciences, or Public Health
- At least 7 years’ experience working with USAID / donor-funded programs, Ministry of Health, and global implementing partners
- Experience
in providing technical assistance to multiple low- and middle-income
countries in regulatory systems strengthening including medicines
evaluation and registration, application of good review guidelines and
good reliance practices, regulatory capacity building
- Experience in building pharmacovigilance systems
- Experience in or knowledge of public health system structure and health policies in Tanzania
- Strong
organizational skills: demonstrated ability to build relationships and
work effectively with senior government officials and other
stakeholders.
- Excellent written and verbal communication, ability to generate lucid reports, and presentation skills in English and Swahili.
MSH
is an equal opportunity employer and will not discriminate against any
employee or applicant for employment on the basis of race, color, sex,
sexual orientation, gender or gender identity, religion, creed,
citizenship, national origin, age, veteran status, or disability
unrelated to job requirements. MSH will take affirmative action to
ensure that qualified applicants are employed and that employees are
treated without regard to their race, age, color, religion, sex, sexual
orientation, gender identity, national origin, veteran and disability
status. In compliance with U.S. Department of Labor Executive Order
11246, Section 503 of the Rehabilitation Act, and Section 4212 of the
Vietnam Era Readjustment Assistance Act, MSH has developed and maintains
an affirmative action program and plan.
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