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