International Consultant on Product Registration

1.       Purpose of the Consultancy

The purpose of this consultancy is to strengthen the Afghanistan Food and Drug Authority’s (AFDA) regulatory capacity in product registration. The consultancy will focus on enhancing dossier evaluation processes, assessing the feasibility of implementing the Common Technical Document (CTD) system and developing a roadmap for its adoption, supporting the development of technical capacity among registration staff, and contributing to the effective implementation of WHO Global Benchmarking Tool (GBT) Institutional Development Plans (IDPs). Through these efforts, the consultancy will ultimately strengthen AFDA’s ability to register medicines and healthcare products efficiently and safeguard public health.

2.       Background

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 , , medicines and medical products registration,, dossier evaluation capcity , CTD adoption,  alignment with GBT sub-indicators related to marketing authorization.. The engagement of an international consultant will provide targeted expertise, hands‑on mentoring, and capacity-building to AFDA staff, supporting the development of sustainable, evidence‑based, and internationally aligned regulatory systems that effectively safeguard public health in Afghanistan.

3.       Planned timelines (subject to confirmation)

Start date:  01/07/2026

End date: 30/09/2026

4.       Work to be performed

Output:

Output 1: Assessment of current product registration and dossier evaluation processes.

Deliverable 1: Develop assessment report on the current dossier evaluation system with gap analysis and recommendations for upgrading to CTD and progress report on implementation of WHO GBT IDPs .

Output 2: Roadmap for CTD adoption.

Deliverable 2: Develop roadmap document outlining the process, timeline, and milestones for transitioning to CTD.

Output 3: Updated regulatory guidelines and SOPs.

Deliverable 3: Prepare registration guidelines and training reports

Output 4: Strengthened capacity of AFDA staff through training.

Deliverable 4: Conduct comprehensive training report documenting the implementation, participation, content, and outcomes of capacity‑building training activities conducted for AFDA staff

5.       Technical Supervision

The selected Consultant will work on the supervision of:

6.       Specific requirements

- Qualifications required:        

Essential: University degree in Pharmacy

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

- Experience required:

 5 to 10 years of relevant experience in pharmaceutical regulation and product registration, with international experience is mandatory

- 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:

•       Excellent knowledge of English

7.       Place of assignment

Kabul, Afghanistan

8.       Medical clearance

The selected Consultant will be expected to provide a medical certificate of fitness for work.

9.       Travel NA

The Consultant is expected to travel according to the itinerary and estimated schedule below:

All travel arrangements will be made by WHO – WHO will not be responsible for tickets purchased by the Consultant without the express, prior authorization of WHO. While on mission under the terms of this consultancy, the Consultant will receive subsistence allowance.

Visas requirements: it is the consultant’s responsibility to fulfil  visa requirements and ask for visa support letter(s) if needed.

Additional Information

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