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WHO provides specialized technical assistance (STA) to support manufacturers and partners in achieving compliance with international regulatory norms and standards, ensuring that health products consistently meet standards of quality, safety and performance. This assistance helps recipients progress towards WHO prequalification (PQ) of priority products or services, emergency use listing (EUL) or risk assessment for the Expert Review Panel (ERP) for medicines or the Expert Review Panel for Diagnostics (ERPD) for in vitro diagnostics (IVDs).
This support targets priority health products and services including critical products for procurement by United Nations (UN) Agencies, their partners and other procurement organizations serving WHO Member States – ensuring access to quality-assured health products where they are most needed.
WHO coordinates targeted, complementary technical assistance to manufacturers and quality control laboratories (QCLs) that are applying, or preparing to apply, to WHO PQ and EUL programmes, covering medicines, vaccines, and IVDs. Workshops and capacity-building initiatives are also organized to promote best practices. These initiatives help manufacturers to align with WHO guidelines and regulatory standards, facilitating progress towards PQ, EUL, and national or regional licensing.
