Market Authorization National Consultant

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 our client 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.

AFDA is regulating the import and export of medicines to ensure that all products entering or leaving the country comply with national regulatory requirements and quality standards. A significant proportion of medicines and health products used in

Afghanistan are imported by international and national non-governmental organizations (NGOs) implementing health programs across the country. In accordance with national regulatory requirements, NGOs importing or procuring medicines locally are required to submit quality assurance documentation and regulatory certificates to AFDA for review and verification.

AFDA therefore has the responsibility to review and verify the authenticity and validity of these certificates to ensure that procured products comply with national regulatory requirements and acceptable quality standards. However, the verification process currently is lengthy in AFDA due to less staff in the mentioned sections for systematic verification and validation of documents issued by AFDA for custom release.

In addition, many NGO technical procurement staff have limited familiarity with AFDA regulatory requirements and documentation standards, which often results in incomplete or inconsistent submissions. This can delay the review process and create challenges for effective regulatory oversight.

To address these challenges, AFDA aims to strengthen and standardize the certificate verification process through the development of a Standard Operating Procedure (SOP) and by enhancing the capacity of NGOs involved in procurement activities. The engagement of a consultant will support AFDA in verifying submitted certificates, developing an SOP for document verification, analyzing verification findings, and providing training to NGO technical procurement staff on regulatory requirements and documentation standards.

Purpose of the consultancy:

The purpose of this position is to support AFDA in verifying the authenticity and validity of certificates submitted by NGOs for local procurement, standardize and strengthen the verification process through the development of SOPs, and build the capacity of NGO technical staff on regulatory requirements and proper documentation standards.

Output:

A finalized SOP for NGO document verification; quarterly analytical reports presenting review of documents issued by AFDA for custom release findings with recommendations; and training modules delivered, with documented training sessions for NGO technical procurement staff.

1. Assist AFDA staff in verifying the authenticity and validity of certificates submitted by NGOs for local procurement, ensuring compliance with national regulatory requirements.

2. Develop a comprehensive Standard Operating Procedure (SOP) for NGO quality assurance document verification to standardize and streamline the process.

3. Prepare and submit quarterly analytical reports summarizing key findings, challenges, and recommendations from certificate-verification activities.

4. Design and conduct training sessions for NGO technical procurement staff on AFDA procedures, regulatory requirements, and documentation standards for market authorization.

Deliverables:

Deliverable 1: Finalized and approved SOP for NGO quality-assurance document verification.

Deliverable 2: Quarterly reports on AFDA certificate-verification findings submitted.

Deliverable 3: Training

modules and materials developed, and documented training sessions conducted for NGO technical staff.

Qualifications and experience:

1. Essential: Specialization/master’s degree in quality assurance or pharmacy

2. Minimum five years’ experience in pharmacy and regulatory and quality assurance documentation

3. Familiarity with our client certification schemes for pharmaceutical products.

4. Experience in developing Standard Operating Procedures (SOPs) and regulatory guidance documents. And experience in conducting training and capacity-building activities for technical or regulatory staff.

Our client Technical Officer-HSD

To be determined

To be determined 

Our client 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 our client Afghanistan office. Please report any

concerning information regarding sexual exploitation and abuse by our client workforce and partners to our client office of Internal Oversight services at [email protected]

our client is a smoke free environment.