CONSULTANT TO PROVIDE TECHNICAL ASSISTANCE TO THE MEDICINES CONTROL AGENCY

..

1. BACKGROUND

The Medicines Control Agency (MCA) of Gambia

Established in 2014, Medicines Control Agency (MCA) regulates medicine and medical products in The Gambia. It is relatively a new agency, going through stages of organizational development.

The core mandate of the agency includes Regulation of all medical products, Licensing, Pharmacovigilance, Quality Control and Post-market Surveillance.

A recent self-assessment of MCA, using a WHO assessment tool suggested that MCA faces multiple challenges including shortage of staff, budget and key operational constraints to executes its mandated roles in importation, registration, surveillance and pharmacovigilance.

These challenges have been further exacerbated due to the recent Covid-19 and Acute Kidney Injury outbreaks. The country faced unexpected surge in pediatrics acute kidney injury, that has been later largely linked with use of DEG/EG contaminated medicines.

MCA has developed an Institution Capacity Development Plan that was informed by the self-assessment and other sources of information. This plan and other existing documents are expected to guide MCA go through an expedited institutional transformation. Currently, MCA in collaboration with the World Bank, it is constructing a quality control laboratory.

The transformation is expected to result in establishing a local quality control and more robust capacity to execute key mandates of the agency. There is an increased expectations from government, public and other stakeholders that these transformations happen expeditiously.

This solicitation for technical assistance is geared towards acquiring technical expertise that for the implementation of these transformation.

2 OBJECTIVES

The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products.

The overall objective of the WHO regulatory system Programme is to support Member States in the WHO African Region to improve the availability of, and equitable access to, quality-assured, affordable medicines, and health products towards the attainment of Universal Health Coverage. The Programme achieves this by developing implementing, and monitoring evidence-based policies, strategies and plans to ensure sustainable access by Member States to essential health technologies, prioritizing cost-effective best practices.

3 PURPOSE

Within the overall framework of the Medicines Control Agency (MCAs) mission and vision and WHO regulatory system mandate, the purpose of this consultancy is to assist MCA’s work on health products and regulatory systems in the Gambia and across the different levels of WHO and among partners, while ensuring their integration in strengthened and resilient health systems. Activities include regulatory systems strengthening, facilitating the adoption of WHO norms, standards and guidance, while supporting the national coalition of interested parties for medical products regulations including on pharmacovigilance, medical devices and the fight against substandard and falsified medical products. S/he also evaluates regulatory systems and functions’ capacity and performance and provides advice on medical products legislation and regulation, while documenting, disseminating, and sharing experiences, best practices and national analytics as well as provides recommendations for strengthening capacity, performance based on institutional development.

4. DESCRIPTION OF DUTIES

• Evaluate the capacity and performance of regulatory systems and functions including legislation, governance, human and financial resources, strategic priorities and planning, enforcement, and implementation using the WHO Global Benchmarking Tool (GBT);
• Develop recommendations for strengthening capacity and performance and establishing institutional development plans (IDP) for the national regulatory authorities;
• Provide technical support for IDP implementation to address regulatory capacity gaps and monitor its progress;
• Promote collaboration, convergence, reliance, and work-sharing between the Gambia and the others regional and international stakeholders;
• Facilitate the adoption of WHO norms, standards, and guidance;
• Facilitate the uptake of WHO regulatory products, including global and regional goods;
• Promote experience-sharing and twinning; and document and disseminate best practices and regional analytics;
• Support the transition to streamlined organizational models to achieve sustainable efficiency of the regulatory systems;
• Facilitate the coalition of interested parties for pharmacovigilance, medical devices, and the fight against substandard and falsified medical products;
• Provide technical support and advice on medical products legislation and regulation;
• Perform other related responsibilities as assigned, including replacing and backstopping for management and other colleagues as required.

Deliverables

1. The Filled self-benchmarking tool for each of the targeted NRA functions and the MCA specific Internal Development Plan (IDP).
2. SOP for prevention, protection and response of substandard and falsified products
3. SOP for market surveillance and market control plan
4. Provide training to MCA staff on key NRA functions
5. Final Technical report

Expected time frame

Three months, preferably starting in April 2023

5 REQUIRED QUALIFICATIONS

Education

Essential : A degree in Pharmacy, Medicine, Chemistry, Microbiology or related sciences, with an advanced qualification in the same or in Public Health. Desirable : Post graduate training or specialization in Medicines Regulation, Pharmaceutics, Healthcare Management, Good Pharmaceutical Practices (GXP), complemented by knowledge and sound understanding of health systems

Experience

Essential : A minimum of ten years relevant experience in pharmaceutical regulatory affairs at the national, regional and international levels, in resource-limited countries, complemented by experience in benchmarking and capacity building of regulatory systems.

Desirable : Familiarity with, quality management principles and project management as well as experience in analysis, and development of training tools and databases for monitoring and evaluation purpose.

Skills

1. Demonstrated ability to evaluate regulatory systems and individual regulatory functions using the WHO Global Benchmarking Tool (GBT) complemented by a proven track record of technical support for adaption, adoption and implementation of norms and standards, and participation participate in advocacy and resource mobilization activities
2. Proven interpersonal skills with ability to promote consensus, communicate progress and results, and resolve issues in a proactive manner, while ensuring effective work practices and ethics: diplomacy, tact, and courtesy.

6. WHO Competencies

1. Producing results 2. Fostering integration and teamwork 3. Communicating in a credible and effective way

4. Respecting individual and cultural differences

Language

Essential: Proficient knowledge of English

7. Place of Work

The place of work is in The Gambia. The MCA particularly the Executive Director or her delegate will manage the consultant. WHO Country office HSS advisor will provide support as required.

Travel: The consultant may be required to travel in the course of his/her duties

Expected renumeration:

Band C: USD 10,000 - 12,500 per month

Grade P4

Please refer to Information Note 09/2021 for guidance on rates for consultants.