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The Afghanistan Food and Drug Authority (AFDA), as the national regulatory authority, is responsible for ensuring the quality, safety, and efficacy of medicines, medical devices, healthcare products, and food. Despite important progress, Afghanistan’s regulatory system continues to face challenges, including limited technical capacity, high dependence on imported products, inconsistent adherence to quality standards, and evolving systems for product registration, inspections, licensing, and market surveillance. Strengthening AFDA’s regulatory functions in alignment with WHO norms and standards is essential to protect public health, prevent substandard and falsified products, and support the country’s broader goals for health system resilience and universal health coverage.

To advance these priorities, AFDA is implementing regulatory reforms guided by the WHO Global Benchmarking Tool (GBT), which provides a structured framework for assessing regulatory maturity and developing Institutional Development Plans (IDPs).

To accelerate progress, specialized technical support is required to strengthen GBT implementation.

Despite important progress in strengthening regulatory functions, Afghanistan continues to face challenges related the national pharmacovigilance system that requires further development to ensure the systematic detection, reporting, analysis, and prevention of adverse events associated with medicines and other health products. As effective pharmacovigilance systems are critical for identifying safety signals, improving the safe use of medicines, and protecting patients from adverse drug reactions and substandard or falsified products. Strengthening pharmacovigilance capacity will also support better regulatory decision-making and improve public confidence in health products available in the country.

To address these priorities, AFDA is implementing regulatory reforms guided by the WHO Global Benchmarking Tool (GBT), which provides a structured framework for assessing regulatory system maturity and developing Institutional Development Plans (IDPs). Strengthening pharmacovigilance functions is a key component of these reforms. However, achieving this objective requires specialized technical expertise to support the implementation of GBT recommendations, improve adverse event reporting mechanisms, strengthen regulatory information systems, and enhance institutional capacity.

Engaging an international consultant will provide targeted technical support, hands-on mentoring, and capacity-building to AFDA staff and relevant stakeholders. This support will contribute to establishing a more proactive and sustainable pharmacovigilance system that aligns with WHO standards and international best practices, ultimately strengthening the protection of public health in Afghanistan.

Purpose of the Consultancy

To strengthen the national pharmacovigilance system in Afghanistan by conducting a comprehensive assessment of institutional and operational gaps, establishing a proactive and standardized adverse event reporting and data management mechanism, supporting the implementation of Institutional Development Plans (IDPs) under the WHO Global Benchmarking

Tool, updating national pharmacovigilance regulatory frameworks in line with international standards, and building sustainable capacity among AFDA staff and relevant stakeholders.

Output:

To strengthen the national pharmacovigilance system by identification of system gaps, establishment of a structured reporting mechanism for adverse events, implementation of pharmacovigilance-related GBT Institutional Development Plans, updated regulatory frameworks, and improved capacity of AFDA staff and key stakeholders

Tasks

1. Review the existing pharmacovigilance framework, including legal, institutional, and operational components; conduct a baseline assessment; identify gaps; and develop a roadmap to strengthen the national pharmacovigilance system.

2. Design and implement a design and pilot a standardized PV reporting mechanism for selected hospitals, clinics, and private sector facilities, including the development of tools for data storage, analysis, and interpretation.

3. Facilitate the implementation of WHO Global Benchmarking Tool (GBT) Institutional Development Plans (IDPs) on pharmacovigilance, monitor progress against agreed indicators, and provide periodic updates to AFDA and WHO.

4. Develop or revise national pharmacovigilance policies, guidelines, and standard operating procedures (SOPs) to ensure alignment with WHO recommendations and international best practices.

5. Plan and conduct training programs and workshops to strengthen the capacity of AFDA staff, health facility focal points, and other relevant stakeholders in pharmacovigilance reporting and system management.

Deliverables:

Deliverable 1: A comprehensive assessment report detailing key gaps and proposed strategies for strengthening the pharmacovigilance system, along with an implementation progress report on WHO GBT Institutional Development Plans (IDPs) related to pharmacovigilance and surveillance.

Deliverable 2: A functional and standardized pharmacovigilance data collection and reporting mechanism established across selected health facilities.

Deliverable 3: Updated national pharmacovigilance policy, guidelines, and SOPs developed and submitted for approval.

Qualifications and Experience:

1. Essential: Advanced degree in Pharmacy or public health

2. Desirable: Specialization/Master’s degree in regulatory or pharmacy

3. Essential: Minimum five years’ experience in pharmacovigilance and medicine safety

Skills / Technical skills and knowledge:

-  Excellent interpersonal and communication skills.

-  High sense of responsibility and strong organizational skills with ability to work under pressure.

-  Advanced computer literacy (Word, Excel, Power point, etc.) Language requirements:

-  Advanced knowledge of Pashtu and Dari

-  Excellent knowledge of English

Additional Information

WHO has zero tolerance for sexual misconduct, inaction against it and any form of retaliation against victims/survivors or bystanders who disclose, report, or participate in an investigation. Parallel to technical competence, recruitment, selection and hiring decisions will give due emphasis to assessing candidates value congruence, thorough background checks and reference check processes. This will ensure children and vulnerable adults are safeguarded from abusers and that abusers are prevented from joining WHO Afghanistan office. Please report any concerning information regarding sexual exploitation and abuse by WHO workforce and partners to WHO office of Internal Oversight services at investigations@who.int

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