Overview
The purpose of this consultancy is to strengthen the Afghanistan Food and Drug Authority’s (AFDA) regulatory capacity in product registration, focusing on enhancing dossier evaluation processes and supporting the implementation of WHO Global Benchmarking Tool (GBT) Institutional Development Plans (IDPs).
Key Responsibilities
- 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.
- Develop roadmap document outlining the process, timeline, and milestones for transitioning to CTD.
- Prepare registration guidelines and training reports.
- Conduct comprehensive training report documenting the implementation, participation, content, and outcomes of capacity‑building training activities conducted for AFDA staff.
Required Experience
5 to 10 years of relevant experience in pharmaceutical regulation and product registration, with international experience is mandatory.
Qualifications
- Essential: University degree in Pharmacy
- Desirable: Specialization/Master’s degree in regulatory or pharmacy