Purpose of the consultancy

The purpose of this consultancy is to assist in strengthening the regulatory systems that ensure the quality, safety and efficacy/performance of medical products including traditional and complementary medicines in resource-limited countries in the Western Pacific Region.

Background

The World Health Assembly (WHA) resolution number 67.20 (2014) emphasizes the role of the World Health Organization (WHO) in strengthening regulatory systems for medical products from a public health perspective, and in supporting national regulatory authorities and relevant regional and international networks in this area.  Essential Medicines and Health Technologies Unit (EMT), Division of Health Systems and Services (DHS), Western Pacific Regional Office (WPRO), continues to support the strengthening of the regulatory systems in the Western Pacific Region (WPR). Despite significant progress, many resource-limited countries (RLCs) are still struggling to implement critical regulatory functions to the minimum level required by the WHA67.20 (2014). Many RLCs in the Region that rely largely on the importation of medicines and vaccines to meet growing public health demand are at greater risk for a lack of access to quality-assured medicines and health technologies.

Strengthening regulatory systems requires a wide range of knowledge and technical expertise in various regulatory functions. Most countries have limited resources to exert all regulatory functions, therefore strategies and approaches need to be resource-considerate and practical. Western Pacific Regional Committee Meeting adopted a resolution RC68.07 (2017) a regional action agenda on the promotion of regulatory cooperation, convergence, and harmonization to address regulatory capacity gaps and to build smarter regulatory systems.

The work of this consultancy contributes to the evaluation of national regulatory systems, application of WHO evaluation tools, evidence generation and analysis of regulatory system performance, facilitating the formulation and implementation of institutional development plans,​ providing technical support to national regulatory authorities and governments and facilitating regulatory cooperation, convergence and harmonization.​

Deliverables

Under the supervision and guidance of the Medical Officer, RSS, EMT, DHS at the WHO Regional Office for the Western Pacific Region, the consultant will conduct desktop research, draft guidance documents and meeting reports, conduct in-country trainings and communicate with the national regulatory authorities (NRAs) and other stakeholders to deliver the following by the end of the contract period:

Methods to carry out the activities:

Output 1: Assist in regional activities of regulatory cooperation and convergence through the work of regulatory network initiatives in the Region
Deliverable 1.1: Logistics and operations of the Western Pacific Regional Alliance Steering Committee virtual meeting in Q1 2025
Deliverable 1.2: Assistance in organizing a planning meeting including drafting and editing the meeting document
Deliverable 1.3: Assistance in organizing the 14th Western Pacific Regional Alliance meeting of the national regulatory authorities with drafting program agenda, discussion papers, speaker nominations, and communications with speakers and participants
Deliverable 1.4: Presentations for technical agendas, draft summary report (within 2 weeks from the meeting) and full report (within 3 months from the meeting)

Output 2: Regulatory systems strengthening through building the capacity and capability of national regulatory authorities by using the WHO Global Benchmarking Tool in the Western Pacific Region, generation of an institutional development plan, and providing technical support in its implementation.
Deliverable 2.1: Assistance in organizing a self-benchmarking workshop for Cambodia: agree on dates through the WHO country office with the NRA; identify external experts; draft mission report
Deliverable 2.2: Technical support upon request by the government for implementing the institutional development plans of Brunei Darussalam, Cambodia, Lao People’s Democratic Republic, Malaysia, Mongolia, Papua New Guinea, Philippines, and Viet Nam

Output 3: Assistance in strengthening the capacity of the national stakeholders in coordination with and guidance from the respective WHO country office to address incidents of substandard and falsified medical products including traditional and complementary medicines (SFMP) and adverse events (AE)
Deliverable 3.1: Updating and maintaining the collaboration networks with the national counterpart in addressing SFMP and AE incidents, including national focal points and laboratory personnel
Deliverable 3.2: Data analysis on SF and AE incidents and country capacity building for risk-based surveillance and laboratory testing

Output 4: Assistance in strengthening the capacity of the national stakeholders in overseeing local production to assure the quality, safety and efficacy of medical products including traditional and complementary medicines.
Deliverable 4.1:  Supporting the regional office session of the third World Local Production Forum on 7-9 April 2025, assisting in concept note development, identifying and engaging panel members
Deliverable 4.2:  Assistance in developing regional strategy and actions to address equitable access through local production

Output 5: Assistance in improving access to essential diagnostics through the development of the national list of essential diagnostics (NEDL)
Deliverable 5.1:  Assistance in coordination with partners on NEDL gap analysis for Brunei Darussalam and Lao PDR
Deliverable 5.2:  Assistance in liaising with partners support NEDL development in Cambodia, and the Philippines.
Deliverable 5.3: Review and draft regional strategy in implementing and reporting on WHA 76.5 strengthening diagnostic capacity.

Qualifications, experience, skills and languages

Educational Qualifications

Essential: University degree in Medicine, Pharmacy, Chemistry or Biologicals or health-related sciences
Desirable: Post-graduate (master’s level) degree in Public Health (or related field)

Experience

Essential: Minimum of five years of proven professional and working experience in qualitative / quantitative research or clinical research or the regulation of medical products
Desirable: Experience on benchmarking of national regulatory authorities in developing countries

Skills/Knowledge

Proven ability to plan and implement new strategies and activities to achieve a goal. Ability to function and communicate effectively. Broad knowledge of the regulation of medical products (e.g., review of product dossiers for quality, safety, and efficacy, pharmacovigilance, clinical trials, regulatory inspections, laboratory access and lot release, and market surveillance) is desirable.
Ability to work effectively with national regulatory authority experts and stakeholders.

Languages and level required

Essential: Expert knowledge of English (writing, reading and speaking)

Location

The consultant will work onsite in Manila, Philippines.

Travel

The Consultant is expected to travel.

Remuneration and budget

Remuneration: Pay band A, USD 6,400 (monthly)
Expected duration of contract: 11 months, February to December 2025

Additional Information:

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Level of Education: Bachelor Degree

Work Hours: 8

Experience in Months: No requirements