Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Guidelines: Norms and Standards for Pharmaceuticals

The norms and standards for pharmaceuticals developed by WHO are prepared through a vast global consultative process involving WHO Member States, national regulatory authorities and international agencies; in consultation with the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations, specialists from industry, national institutions, nongovernmental organizations, and so on. These draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, are thereafter adopted as international standards. 

This web page links to all current WHO norms and standards for pharmaceuticals guidelines which are grouped into (1) development, (2) production, (3) distribution, (4) inspection, (5) quality control, (6) regulatory standards and (7) specific texts for prequalification of medicines.

The guidelines under development/for comment are under working documents in public consultation.  


Quality assurance of pharmaceuticals: a compendium of guidelines and related materials

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: volume 1: Good practices and related regulatory guidance, 10th ed

This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over...

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: volume 2: Good manufacturing practices and inspection, 10th ed

This publication guides the manufacturing and quality control of pharmaceuticals, vaccines and other biologicals, and other medical products...

Guidelines

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