In the competitive and highly regulated world of pharmaceuticals, getting your product prequalified by the World Health Organization (WHO) can unlock global procurement opportunities and boost your credibility.
What Is WHO Prequalification?
WHO Prequalification of Medicines Programme (PQP) is a service provided by WHO to assess the quality, safety, and efficacy of medicines. The goal is to ensure that only high-quality pharmaceuticals are procuread by United Nations agencies and other global health stakeholders.
The prequalification is especially relevant for multisource (generic) pharmaceutical products that aim to treat priority diseases such as HIV/AIDS, malaria, tuberculosis, and others. Once prequalified, your product is listed on the WHO website, making it eligible for purchase by international procurement agencies like UNICEF, the Global Fund, and others.
In essence, prequalification acts like a global passport for your medicine, allowing broader market access, increased visibility, and enhanced trust.
WHO Prequalification: The End-to-End Process
Getting prequalified is not just about filling out a form. It is a rigorous, multi-step process that evaluates your product’s quality, safety, efficacy, manufacturing site compliance, and regulatory documentation. Here’s how it works:
- Expression of Interest (EOI) Start by submitting an EOI in response to a call for medicines published by WHO. This outlines your intention to have a specific medicine evaluated and includes basic information about your product.
- Preparation of the Product Dossier (PD) You will need to compile a Product Dossier (PD) following the Common Technical Document (CTD) format. This is broken down into modules:
- Module 1: Regional information (admin/legal).
- Module 2: Quality Overall Summary (QOS-PD) — a concise summary of Module 3.
- Module 3: Detailed data on quality aspects of the API and FPP (finished pharmaceutical product).
- API details: manufacturing, quality control, stability.
- FPP details: formulation, manufacturing process, specifications, container-closure system, and stability data.
- WHO prequalified API
- Certificate of Suitability (CEP)
- API Master File (APIMF)
- Full details in the dossier
- Dossier Assessment by WHO WHO conducts a scientific review of the dossier. This includes assessment of:
- Compliance with ICH/WHO quality guidelines.
- Consistency and completeness of data.
- Adequacy of control measures.
- Manufacturing Site Inspection WHO conducts Good Manufacturing Practice (GMP) inspections at both the API and FPP manufacturing sites to ensure compliance with WHO GMP standards.
- Product Testing In some cases, WHO may also test product samples in a WHO-designated laboratory.
- Prequalification Decision If everything meets WHO requirements, your product is added to the List of Prequalified Medicinal Products, enabling you to participate in global health tenders.
Challenges Faced During Prequalification
Many applicants underestimate the amount of preparation needed. Common hurdles include:- Incomplete or inconsistent quality data
- Non-alignment with WHO’s CTD format
- Insufficient GMP documentation
- Inadequate validation of analytical methods
- Missing or weak stability data
How Masuu Pharma Can Help You
At Masuu Pharma Quality and Regulatory Consultants, we specialize in guiding pharmaceutical companies through the complete WHO prequalification process — from initial planning to final approval.
Our services include:- Gap Analysis: We assess your existing documentation and processes against WHO requirements.
- Dossier Preparation: We help build or revise CTD-compliant product dossiers (Modules 1–3).
- Quality Strategy: We ensure your data on API and FPP (including stability, specifications, and validation) meet WHO standards.
- GMP Readiness: We conduct mock inspections and train your team to prepare for WHO GMP audits.
- Regulatory Submissions: We manage submissions and responses to WHO queries (screening and assessment phases).
- Lifecycle Support: We assist with post-approval variations, renewals, and requalification.
With our deep knowledge of WHO TRS 970 Annex 4 and TRS 986 Annex 6 guidelines, we ensure that your dossier is technically sound, strategically structured, and submission-ready.