How EMA Harmonizes GMP Standards with WHO PQP and PIC/S

As pharmaceutical markets expand and supply chains globalize, regulatory convergence is becoming essential. The European Medicines Agency (EMA) actively collaborates with international bodies to harmonize inspection standards, align GMP expectations, and reduce duplication of effort. Two major platforms in this endeavor are the World Health Organization’s Prequalification Programme (WHO PQP) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This article explores EMA’s harmonization with WHO PQP and PIC/S, examining its impact on inspection methodology, global GMP standards, and cross-border regulatory alignment.

Understanding WHO PQP and PIC/S

• WHO PQP: Assesses GMP compliance for medicines supplied to developing countries through UN and donor-funded procurement
• PIC/S: A voluntary international arrangement of GMP inspectorates committed to global harmonization of inspection procedures
• EMA engages with both to promote consistent quality, safety, and efficacy standards globally

EMA’s Role in Global Regulatory Harmonization

• EMA is a recognized collaborating partner of WHO and a full member of PIC/S since 1995
• Coordinates inspection strategies and technical cooperation via its GMDP Inspectors Working Group
• Engages in joint inspections, inspector training, and shared regulatory reports with WHO and PIC/S partners
• EMA’s inspection model often serves as a global benchmark for pharmaceutical GMP compliance

EMA and WHO PQP Alignment

• EMA aligns its GMP guidelines (EudraLex Volume 4) with WHO Technical Report Series (TRS) 986 and 1025
• EMA participates in WHO PQP inspections in low- and middle-income countries (LMICs)
• WHO PQP often adopts EMA inspection outcomes and certificates for prequalification decisions
• EMA contributes to WHO guideline development and capacity-building workshops
• Supports data integrity, GMP for biologicals, and stability testing alignment

Joint EMA-WHO Inspections

• Conducted in Africa, Asia, and Latin America for vaccine, antibiotic, and HIV product sites
• Enhances trust in WHO-prequalified products for procurement agencies
• Reduces inspection redundancy for manufacturers supplying multiple jurisdictions
• EMA shares inspection findings with WHO PQT via secure channels for harmonized decision-making

PIC/S: Harmonizing GMP Inspection Standards

• PIC/S includes over 50 member authorities such as the FDA (USA), TGA (Australia), Swissmedic, and ANVISA (Brazil)
• EMA collaborates with PIC/S on:
  • GMP training and joint inspector certification
  • Inspection templates and aide-memoires
  • Data integrity and computerized system audit practices
  • GMP harmonization for advanced therapy medicinal products (ATMPs)
• Participation ensures mutual reliance and greater consistency in GMP inspections globally

GMP Inspection Tools Shared Across Agencies

• EMA and PIC/S use harmonized inspection forms and risk-based planning models
• EMA inspection findings are often accepted by WHO PQP and PIC/S members
• Adoption of the same audit terminology (e.g., critical/major/other deficiencies)
• GMP non-compliance statements posted on both EudraGMDP and WHO databases

Benefits of EMA Harmonization with WHO and PIC/S

• Reduces inspection fatigue for global manufacturers
• Accelerates time-to-market for essential medicines and vaccines
• Improves product quality through shared best practices and inspections
• Builds trust in internationally distributed pharmaceutical products
• Enables resource-sharing and capacity building in developing regulatory systems

Examples of Regulatory Convergence

• EMA and WHO jointly update guidance on cold chain, cleanroom qualifications, and biologics handling
• Training modules for GMP inspectors developed by EMA are used in PIC/S inspector training courses
• Mutual acceptance of Certificate of GMP Compliance for prequalification and registration purposes
• Global recall coordination efforts for product quality or contamination incidents

How Manufacturers Can Leverage Harmonization

1. Use GMP systems and documentation formats aligned with EMA and PIC/S inspection expectations
2. Apply for WHO PQP using existing EU GMP compliance records to streamline review
3. Participate in EMA scientific advice and WHO regulatory briefings to stay informed
4. Prepare for inspections using PIC/S harmonized templates and audit trails
5. Design global Quality Management Systems (QMS) that accommodate both EU and WHO standards

EMA’s Role in Global Capacity Building

• Conducts regulatory training missions with WHO for inspectorates in emerging economies
• Provides case studies and audit simulations in global workshops
• Supports reliance pathways where smaller authorities defer to EMA/WHO inspections
• Fosters regulatory convergence through ICH and regional harmonization groups

Conclusion

EMA’s collaboration with WHO PQP and PIC/S exemplifies a modern, risk-based, and globally integrated approach to GMP inspection and pharmaceutical regulation. By harmonizing standards, sharing tools, and conducting joint inspections, these organizations reduce duplication, enhance oversight, and promote patient access to high-quality medicines. Manufacturers who embrace these harmonized expectations position themselves for smoother global compliance, broader market access, and regulatory trust across jurisdictions.