Understanding the WHO Prequalification Program: Scope, Process, and Global Impact
The WHO Prequalification Program (PQP) is one of the most influential regulatory frameworks in the global public health landscape. Designed to ensure the safety, efficacy, and quality of essential medicines, diagnostics, vaccines, and active pharmaceutical ingredients (APIs), the WHO PQP plays a vital role in shaping access to healthcare in low- and middle-income countries (LMICs). This article provides an in-depth overview of the program’s scope, operational process, inspection framework, and its significance in the global health ecosystem.
What Is the WHO Prequalification Program?
Launched in 2001 by the World Health Organization (WHO), the PQP aims to evaluate and qualify health products that meet WHO’s international quality standards. Once prequalified, these products are eligible for procurement by UN agencies, Global Fund, GAVI, and other international donors.
Scope of the WHO PQP:
The program covers a broad range of health products, including:
- Finished pharmaceutical products (FPPs)
- Active pharmaceutical ingredients (APIs)
- Vaccines and immunization-related products
- In vitro diagnostics (IVDs) and laboratory equipment
- Vector control products (e.g., insecticide-treated nets)
Objectives of the WHO Prequalification Program:
- Ensure availability of quality-assured medicines and health products
- Support regulatory convergence and reliance among national authorities
- Promote GMP, GDP, GCP, and GLP compliance in LMICs
- Reduce time and cost of regulatory duplication for manufacturers
- Enable access to life-saving treatments through global procurement platforms
The WHO PQ Process: Step-by-Step
1. Expression of Interest (EOI)
WHO issues EOIs inviting manufacturers to submit applications for specific product categories (e.g., antiretrovirals, antimalarials). Applicants must demonstrate GMP compliance and product registration in a reference market.
2. Dossier Assessment
Technical experts review the Common Technical Document (CTD) or product dossier for safety, efficacy, and quality. This includes evaluating bioequivalence studies, stability data, and manufacturing controls.
3. GMP and GCP Inspections
On-site inspections are conducted at the manufacturing site and clinical trial sites (if applicable). Inspections follow WHO GMP guidelines (TRS 986, 981, and 961) and cover:
- Facility and equipment validation
- Personnel qualifications and SOP adherence
- Data integrity and batch records
- Stability testing compliance per ICH Q1A
- Documentation, quality management systems, and CAPA
4. Quality Control Laboratory Evaluation
Analytical labs performing product testing must meet WHO GLP standards. The PQP inspects and prequalifies laboratories under a separate accreditation process.
5. Product Prequalification and Listing
Upon satisfactory dossier review and inspection results, the product is listed on the WHO PQ database and becomes eligible for UN procurement and donor funding programs.
Post-Prequalification Obligations:
- Ongoing stability monitoring and submission of annual product quality reports
- Notification of variations and lifecycle changes
- Periodic re-inspections (typically every 3 years)
- Transparent handling of quality complaints and adverse events
Global Significance of the WHO PQP:
1. Facilitating Procurement by Global Health Organizations
Entities like UNICEF, Global Fund, and GAVI procure only WHO-prequalified or SRA-approved products, making WHO PQ a gateway for global market access in public health supply chains.
2. Strengthening National Regulatory Systems
WHO PQ supports regulatory convergence by providing guidance, training, and capacity-building to National Regulatory Authorities (NRAs). Many countries adopt PQ inspection findings through reliance or recognition frameworks.
3. Promoting Innovation and Generics Competition
By reducing regulatory barriers, WHO PQ encourages generic competition, helping lower treatment costs for HIV, TB, malaria, and non-communicable diseases.
Prequalification vs. National Registration:
While WHO PQ does not replace national drug registration, it accelerates the process. Through the Collaborative Registration Procedure (CRP), countries fast-track market authorization for PQ-listed products within 90 days using WHO findings.
Challenges in WHO PQ Participation:
- Stringent dossier preparation requirements
- Long assessment timelines (up to 12–18 months)
- High cost of remediation and CAPA implementation after inspections
- Language and formatting issues for non-ICH regions
Best Practices for Manufacturers Seeking WHO Prequalification:
- Conduct a self-inspection using WHO PQ audit checklists
- Invest in robust QMS and electronic batch record systems
- Align SOPs with WHO GMP expectations and ICH standards
- Prepare a variation plan in advance for potential post-approval changes
- Use WHO-prequalified APIs and labs to streamline review
Key Role of Quality Assurance (QA):
QA teams play a pivotal role in preparing for WHO inspections, managing documentation, coordinating CAPA responses, and sustaining GMP compliance post-approval. They are responsible for:
- Training staff on WHO-specific requirements
- Overseeing audit readiness across global sites
- Maintaining version control of SOPs and submission documents
- Monitoring inspection trend data and quality KPIs
Conclusion:
The WHO Prequalification Program is more than just a certification pathway—it’s a cornerstone of global health supply chains, regulatory harmonization, and patient access to quality medicines. For pharmaceutical manufacturers, participation in the program not only opens doors to international markets but also validates their commitment to global quality standards. As global health priorities evolve, WHO PQ will remain central to ensuring that the right products reach the right people—safely, effectively, and affordably.