In 1977, WHO, the World Health Organisation, drew up its first list of essential medicines (EML). The EML, adapted in more than 150 WHO Member States, is a landmark for the prioritisation of medicines in the public sector of health systems.

Since at least 1988[1], WHO has addressed the serious issue of the quality of medicines and other medical products, such as vaccines, laboratory products and medical devices. In 2002, it began its own drug prequalification program. Prequalification of medicines is a service provided by WHO to evaluate the quality, safety and efficacy of medical products (source-manufacturer).

Initially, the emphasis was on drugs to treat HIV / AIDS, tuberculosis and malaria. In 2006, the Program was expanded to include drugs and products for reproductive health. In 2008, prequalification of zinc – for the management of severe acute diarrhoea in children – was included. More recently, drugs for neglected tropical diseases and infectious hepatitis have been added (and, a few days ago, some biosimilars used against cancer). There is also a prequalification program for vaccines, and one for in vitro diagnostic tests.

Since 1947, the Expert Committee on Specifications for Pharmaceutical Preparations has been advising the Director General of WHO and Member States and has published guidelines on all specifications for pharmaceutical products and systems. In this context, for example, in 2007 WHO published its MQAS, Model Quality Assurance System for Drug Supply Agencies (latest version 2016) for the first time, which aims to be a guide for the quality systems of all supply agencies.

At present, WHO is expanding its bank of guidelines by publishing the WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices.

Today, there are an estimated 2 million different types of medical devices available on the world market that fall into more than 22,000 generic forms. In this jungle, falsified or sub-standard medical products abound, not just in low-income countries. We recall the scandal of silicone-based breast implants. By May 2017, the WHO World Assembly had adopted a resolution to set up a framework that targets, as never before, health technology and, more specifically, medical devices.

What is crucial is that this model document is intended to provide guidance and support to WHO member states that still need to develop and implement legal controls on medical devices. Many countries have neither the financial resources nor the technical expertise to pass successfully and quickly from an unregulated market to comprehensive legislation on medical devices. Instead, the WHO Model recommends a phased approach to regulating the quality, safety and efficacy of medical devices. It provides guidance for the development of a control system. It starts from a basic level of control such as the promulgation of the law and the renewal of the regulatory enforcement authority; then the regulatory authority moves to more targeted controls such as inspection of registered establishments and monitoring of clinical studies.

The model is certainly a technical document, but it is very relevant for buyers, supply agencies, regulatory authorities, and for those who provide training in the quality of medical products.

QUAMED, an independent non-profit association promoting quality medicines in the world, is dedicated to improving the quality of medicines in low-income countries.


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[1] In 1988, the World Health Assembly (WHA) resolution 41.16 requested to ‘initiate programmes for the prevention and detection of export, import and smuggling of falsely labelled, spurious and counterfeited or substandard pharmaceutical preparations’.