Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

WHO provides specialized technical assistance (STA) to help recipients achieve compliance with international regulatory norms and standards, so that they can attain WHO prequalification (PQ) for priority products or services, emergency use listing (EUL) and/or risk assessment for the Expert Review Panel (ERP) for medicines / Expert Review Panel for Diagnostics (ERPD) for IVDs. This applies to priority products or services and/or supply of quality-assured products required by United Nations (UN) Agencies, their partners and procurement agencies serving WHO Member States. The Local Production & Assistance Unit (LPA) supports the PQ or EUL of medicines, vaccines, and in vitro diagnostics, by providing complementary PQ/EUL-related technical assistance to manufacturers and quality control laboratories (QCLs) applying or planning to apply to the WHO PQ or EUL programmes.

Workshops are also organized to enhance the understanding and promote best practices amongst manufacturers on quality requirements for medical products as described in the WHO guidelines and other regulatory authorities for PQ, EUL and licensing purposes.

 

 

Specialized Technical Assistance for WHO PQ and EUL

Technical Training for WHO PQ and EUL