PSUR Central – Global PSUR & PBRER Services
Strengthening Pharmaceutical Safety in Afghanistan: AFDA | MoPH | WHO Compliance
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for pharmaceutical importers, domestic manufacturers, and international NGOs operating in the Islamic Emirate of Afghanistan.
As the Afghanistan Food and Drug Authority (AFDA) continues to centralize regulatory oversight and crack down on illicit and sub-standard medicines, the requirement for robust pharmacovigilance (PV) is more critical than ever. We support partners in Kabul, Kandahar, and Herat in ensuring that every medicinal product—whether imported from regional hubs or manufactured locally—is backed by scientifically sound safety documentation that meets WHO Maturity Level 3 aspirations.
Who We Support in Afghanistan
We provide specialized pharmacovigilance expertise to the vital stakeholders of Afghanistan’s healthcare recovery:
Pharmaceutical Importers & Supply Companies: Ensuring that medicines imported from Pakistan, India, Iran, and the EU are accompanied by "authority-ready" global safety dossiers required for AFDA registration.
Domestic Manufacturers: Assisting the growing number of local factories in Kabul and Herat in implementing internal PV systems and drafting their first post-market safety reports.
NGOs & International Aid Partners: Providing aggregate safety summaries for essential medicines and vaccines distributed under national health programs and humanitarian initiatives.
Regulatory Compliance Officers: Supporting local safety officers in navigating the AFDA Medicine Registration Guidelines and the National Medicines Policy (NMP).
Our PSUR & PBRER Services
Our scientific excellence is designed to bring international rigor to Afghanistan's pharmaceutical market:
WHO-Aligned PSUR Drafting: Professional preparation of safety reports following the WHO Guidelines for setting up and running a PV Centre, tailored for the Afghan regulatory context.
ICH E2C (R2) PBRERs: Comprehensive benefit-risk evaluations that justify the continued safety profile of products in the unique clinical environment of Afghanistan.
Signal Detection for the Afghan Market: Assisting in the evaluation of adverse drug reactions (ADRs) reported through the National Pharmacovigilance Committee.
Post-Market Surveillance Support: Helping companies comply with the AFDA’s increasing focus on monitoring the quality and safety of marketed health products.
Registration Dossier Support: Ensuring that Module 5 (Safety) of your registration dossier is complete and scientifically defensible during the AFDA review process.
Why Partners in Afghanistan Choose PSUR Central
"Committed to the quality and safety of medicines for every Afghan citizen."
AFDA Insight: We stay updated on the latest circulars from the Deputy Ministry of Food and Drugs, ensuring your documentation reflects current Kabul mandates.
Global Quality, Local Expertise: We bring the technical standards of a global firm while understanding the specific challenges of the Afghan supply chain, including the need to combat smuggling and sub-standard drugs.
Audit-Ready Documentation: Our reports are designed to withstand scrutiny during AFDA inspections and meet the requirements of international donor organizations.
Capacity Building: We don't just provide reports; we act as a thought partner to help your local team understand global pharmacovigilance best practices.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
AFDA Medicine Registration Guidelines: The primary framework for drug approval in Afghanistan.
National Medicines Policy (NMP): The strategic foundation for pharmaceutical services in the country.
WHO Good Pharmacovigilance Practices: The global benchmark used by the AFDA to strengthen its regulatory functions.
ICH E2C (R2): The international standard for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your operations in Afghanistan, we typically require:
Product Portfolio and the origin of the medicines (e.g., India, Pakistan, Iran, EU).
AFDA Registration Status: Current or pending registration details for the Afghan market.
Approved Labeling: The Dari, Pashto, or English labeling and Reference Safety Information (RSI).
Local Safety Data: Any ADR reports collected via the local Afghan distribution network.
Submission Deadlines: Per the requirements of the AFDA Pre-Market or Post-Market Directorates.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Afghanistan is scientifically robust and authority-ready.
Global PSUR Compliance. Science-Driven. Authority-Ready.