Specialist - MHRA Structure and Governance

Job Description

This is an excellent opportunity to contribute to significant health sector reforms in Bangladesh, working closely with key stakeholders such as the Ministry of Health and Family Welfare and the World Health Organization. The role offers a unique chance to shape the future of healthcare in the country and gain valuable experience in international health development.

The Ministry of Health and Family Welfare (MoHFW) is implementing a range of reform measures to strengthen the resilience, efficiency, and equity of the health system in line with the recommendations of the Health Reform Commission (2025). These reforms aim to align Bangladesh’s health system with the principles of equity, participation, and accountability ensuring that health is realized as both a constitutional right and a public good. In this regard, the Ministry has prepared a comprehensive proposal titled “Health Sector Transformation in Bangladesh”, outlining the strategic priorities, implementation modalities, and expected outcomes of the reform agenda. The proposal emphasizes eight key strategi areas including governance and institutional reform, primary healthcare restructuring, workforce planning, financial sustainability, digital transformation, medicine regulation, documentation of transition strategies, and stakeholder communication.

The Ministry seeks the technical and strategic partnership of the World Health Organization (WHO) to support the implementation of these reform initiatives. WHO will provide technical assistance, policy advice, and coordination support to ensure that the reform measures are effectively implemented and aligned with global best practices in health system strengthening.

The purpose of this consultancy is to develop a comprehensive proposal on new governance framework, operational rules, and organogram for the Medicine and Health Regulatory Authority (MHRA) . The proposal should incorporate best practices from the regional and global standards, tailored to the local context.

Objectives of the Assignment

• To review the existing legal frameworks, current DGDA’s structure, functional units, committees, mandates, staffing, and decision-making processes, and identifying gaps, overlaps, inefficiencies, and capacity constraints affecting licensing, quality control, market surveillance, pharmacovigilance, enforcement, pricing on the medical products.
• To design a modern regulatory framework for the proposed MHRA by benchmarking against the best international and regional practices, proposing a detailed organogram, governance framework, operational rules and implementation roadmap.
• To provide a transition and implementation roadmap from DGDA to MHRA by recommending legal, administrative, and human resource changes, outlining necessary capacity-building and infrastructure improvements, and ensuring operational measures for a smooth and effective institutional transformation.

The consultant will undertake the following tasks:

Situational Analysis: 

• Review relevant legal, policy, and strategic documents (including the Drug & Cosmetics Act 2023, National Drug Policy), DGDA mandates, organograms, Quality Manual, key standard operating procedures on pre- marketing control and post marketing control.
• Conduct consultations with DGDA function heads, Divisional heads and district offices; map functional units, committees, staffing, reporting lines, regulatory processes, and decision flows; identify gaps, bottlenecks, and capacity constraints.

Benchmarking and Best Practices: 

• Analyze international and regional regulatory authorities with similar mandates to identify effective structures, governance models, Rules of Business, digital systems, human resource capacity, lab infrastructure, and enforcement mechanisms applicable to MHRA.

Design of MHRA Structure and Rules of Business: 

• Propose a detailed organogram with directorates, divisions, functional units, staffing levels, roles, competencies, and reporting lines.
• Draft Rules of Business covering decision-making authority, delegation, licensing, compliance/enforcement, stakeholder engagement, transparency, and operational policies including ethics, conflicts of interest, and grievance procedures.
• Recommend legal, administrative, HR, and resource steps for transitioning from DGDA to MHRA (additional or changed mandates).

Transition and Implementation Plan

• Outline key institutional development plan, capacity building, training, and stakeholder engagement; provide rough cost estimates for structural, staffing, and infrastructure enhancements.

Expected Deliverables:

Sl. No.

Activities

Deliverables

Timeline

1

Situational and Benchmark Analysis –

Conduct a comprehensive assessment of DGDA’s existing structure, mandates, functions, SOPs, and governance processes; benchmark against regional and international best practices (e.g., MHRA-UK, US-FDA, EMA, CDSCO India).

Situational and Benchmark Analysis Report –

Detailed analytical report mapping DGDA’s current structure, functions, and performance, with comparative analysis of global and regional regulatory authority models to inform MHRA design.

Day 1–15

2

Development of Draft MHRA Structure and Rules of Business – Design a consolidated organizational proposal outlining the new MHRA structure, including directorates, divisions, and staffing framework; prepare draft Rules of Business defining decision-making, regulatory authority, and coordination mechanisms.

Draft Proposal for MHRA Structure and Rules of Business –

Comprehensive proposal including detailed organogram, role definitions, reporting hierarchies, operational workflows, and draft Rules of Business covering governance and transparency mechanisms.

Day 16–30

3

Preparation of Transition and Implementation Plan –

Develop recommendations and roadmap for the DGDA-to-MHRA transition, covering legal, administrative, HR, and financial dimensions; identify required reforms, capacity-building needs, and resource allocations.

Transition and Implementation Plan –

Action-oriented roadmap with timelines, responsibilities, training plan, and indicative cost estimates for transition and operationalization of MHRA.

Day 31–40

About the Organization

United Nations Office for Project Services