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.

Support to regulatory authorities

National Medicines Regulatory Authorities and manufacturers face two challenges in ensuring the quality and safety of blood products and related in vitro diagnostic devices.

First, the risk of contamination through blood-borne pathogens like HIV, hepatitis B and hepatitis C which cause life threatening diseases world wide. Second, the difficulties in validating quality assurance systems due to the inherent variability of biological products.

National Regulatory Authorities need to be competent, independent, with strong political backing and have clear authority to develop and enforce appropriate regulations. They also need to interact closely with medical and scientific institutions and civil society organizations representing health care users and professionals in the countries.

Unfortunately, the National Regulatory Authorities in many countries often do not have this type of professional structure. Efforts should therefore be made to strengthen technical capacity and expertise of National Regulatory Authorities worldwide. Technical and regulatory guidance is provided on main topics in this Web Site (see left side). Information is also available in the Recommendations made by the International Conference of Drug Regulatory Authorities (ICDRA) that has served, since 1980, as a global forum to meet and discuss ways of strengthening collaboration.


Focus areas

Meeting reports

Multi-country outbreak of mpox, External situation report_66

This is the 66th situation report for the multi-country outbreak of mpox, which provides details on the global epidemiological situation for mpox, including...

In April 2026 (epidemiological weeks 14 to 17), a total of 20 100 new cholera and acute watery diarrhoea (AWD) cases were reported from 15 countries, territories,...

Middle East Conflict global situation report 28 May 2026

This is the eighth global public WHO situation report on the conflict in the Middle East. It covers the health situation and WHO operational updates from...

In week 20 2026, influenza positivity remained below 10% and SARS-CoV-2 activity remained low globally and in the northern hemisphere temperate and subtropical...

20260526_BVD_DRC & Uganda

This Rapid Risk Assessment (RRA) aims to assess the risk of Ebola disease caused by Bundibugyo virus in the Democratic Republic of the Congo and Uganda,...

This risk evaluation summarizes current evidence on Rift Valley fever (RVF) virus, provides a risk evaluation based on the latest evidence, assesses the...

Curso sobre cuentas de salud - Módulo 3, Submódulo 3.2

El submódulo 3.2, « Principio triaxial, dimensiones y clasificaciones», explica el principio de la perspectiva triaxial del SHA 2011,...

Учебный курс "Счета здравоохранения" - Модуль 3, Подмодуль 3.2

Подмодуль 3.2, «Принцип трёхосности, его измерения и классификации», объясняет принцип триаксиальности SHA 2011, его измерения и классификации.  

Cours sur les comptes de la santé - Module 3, Sous-module 3.2

Le sous-module 3.2, « Principe de triaxialité, dimensions et classifications », explique le principe de triaxialité du SHA 2011,...