Consultancy to Provide Technical Assistance on Establishing/Strengthening the Food and Drug Administration (FDA) System

Call for Expressions of Interest and Proposal

# 028 – Job title: To provide technical assistance on establishing/strengthening the Food and Drug Administration (FDA) system to support WHO CO in Viet Nam.

1. Background

In January 10, 2014, Vietnam Prime Minister issued Decision No.68/QD-TTg of the “National Strategy on Development of the Viet Nam Pharmaceutical Sector up to 2020, with a vision toward 2030”. According to the strategy, the Ministry of Health (MoH) shall research and propose with the government to elaborate a model of unified, concentrated, comprehensive and effective management agencies dealing with pharmaceutical products, food, cosmetics and products directly influencing human health under the MoH. Further, pursuant to the resolution 20-NQ/TW issued in October 25, 2017 by the Central Committee, as part of the major tasks and solutions, it mentioned renovating the system of health sector’s organizational structure towards streamlined, efficient and effective, internationally integrated as well as promoting the development of the pharmaceutical sector. The current health expenditure per capita (PPP, current international $) had been surged at approximately 4.4 times from 99.3 in 2000 to 440.2 in 2018, including a huge portion of pharmaceutical expenditure.

WHO has supported the National Regulatory Authority (NRA) Vietnam to ensure the quality, safety, and efficacy of medicinal products as well as to enhance access for people to the essential medicine in Viet Nam. In 2020 December, the Vietnamese NRA attained vaccine regulatory system (except one function of market surveillance and control) as Maturity Level 3 assessed by the WHO Global Benchmarking Tool (GBT) revision V. One of the assessment recommendations was to establish an autonomous and comprehensive NRA in Viet Nam.

2. Objective

The main objective of the consultancy assignment is to provide technical assistance on establishing/strengthening the Food and Drug Administration (FDA) system to support the Universal Health Coverage Team of the World Health Organization Representative Office in Viet Nam. The required technical support will include the guidance of the country’s situation analyses and review, facilitation of cross-country experience sharing, and preparation of a policy brief.

3. Work to be performed

Method(s) to carry out the activity

The consultant will work remotely and be required to report regularly to the WHO Viet Nam Office located in Hanoi under the direct supervision of the UHC Team Coordinator and closely work with a Go WHO Fellow in charge of essential medicines and NRA strengthening as a team.

The work will involve but not be limited to:

• Facilitating collaboration among analysis report researchers, VNM research institution, if necessary, Viet Nam NRA Office;
• Proactively participating and communicating in meetings and webinars
• Reviewing analysis reports and documents
• Development of a policy brief
• Providing technical advice where needed

Details and timeline are provided as below (see Annex 1 for timeline and number of days expected for each deliverable):

Output/s

Output 1: Technical support on country analysis for Viet Nam

• Deliverable 1.1: Inception report for country analysis including its timeline, methodology and rationale
• Deliverable 1.2: Power point presentation for a kick-off online meeting to guide and discuss with VNM research institution
• Deliverable 1.3: Minutes of discussions after online meeting with VNM research institution
• Deliverable 1.4: Review/comment of the report

Output 2: Technical support on webinar series of learning and sharing experience from other countries; support on country approach and networking; Facilitation of webinars; Quality control of webinar content (PPT) by reviewing and commenting

• Deliverable 2.1: Review/comment of webinar PPT
• Deliverable 3.1: Power point presentation on the result of country analysis and policy brief

Output 3: Produce a policy brief report, summarizing the country analysis as well as a set of recommendations and follow-up actions

• Deliverable 3: The policy brief report

4. Specific requirements

a. Qualifications required:

• Essential: Advanced degree in medicine, pharmacy or public health from a recognized university
• Desirable: Specialization in clinical pharmacology and Essential Medicines

b. Experience required:

Essential: A minimum of ten (10) years of experience in medicines, medicines regulations and health care systems in national, regional and international organizations; led projects on Essential medicines, Standard guidelines, Medicines regulations, etc; worked on medicine legislation and regulation; experience in a national regulatory authority (NRA) or supporting NRA systems strengthening at international setting and working knowledge of pharmaceutical system and/or management.
Desirable:

• Experience on WHO Global benchmarking Tool (GBT) for NRA in Low- and Middle-Income Countries (LMICs); Experience on a member of international advisory groups in the international organization
• Experience in working in international organizations or UN and in Viet Nam in the area relevant to this consultancy work.

c. Skills / Technical skills and knowledge:

• Good knowledge on the lifecycle of medicine in national regulatory systems
• High level analytical and conceptual skills to improve capacity of National Regulatory Authorities
• High level of computer literacy including Microsoft excel and power point
• Proven ability to synthesize complex information to show good judgement and to generate approaches
• Ability to work independently, to prioritize tasks and to set schedules to meet specified deadlines
• Excellent written communication skills, including proven ability to write clear and concise documents, including reports, submissions and briefing documents

d. Language requirements:

Essential: Expert knowledge of English

e. Competencies

• Excellent interpersonal and communication skills
• Demonstrated ability to work as part of a team or independently
• Produces results
• Builds and promotes partnerships
• Fosters integration and teamwork

5. Place of assignment

Will be conducted remotely

6. Medical clearance

As the vacancy posting is for an off-site short-term consultant, a medical clearance is not required.

7. Travel

The Consultant is not expected to travel according to the itinerary and estimated schedule below:

8. Budget

The contractor will be responsible for paying taxes, if any.

Those who are interested can contact our focal person with contact detail at the end of the announcement before/by 07 June 2021 and should be addressed to:

Administrative Officer
World Health Organization
UN Building, 304 Kim Ma Street,
Hanoi, Viet Nam

OR
[email protected]

For further information on this TOR, please contact:
[email protected]