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Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality - WHO Policy Perspectives on Medicines, No. 007, November 2003
(2003; 6 pages) [French] [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoWhy must medicines be regulated?
Ver el documentoWhat is medicines regulation?
Ver el documentoWhat makes medicines regulation effective?
Ver el documentoKey elements for ensuring effective regulation
Ver el documentoNational regulatory authorities in an international context
Ver el documentoKey documents

Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality - WHO Policy Perspectives on Medicines, No. 007, November 2003

November 2003
World Health Organization

Currently about 20% of countries have well developed and operational medicines regulation. Of the rest approximately half have regulation of varying capacity and level of development, and 30% have either no or very limited medicines regulation. The reality is that many low-income countries cannot ensure the safety, efficacy and quality of medicines circulating on their markets. The problems of ineffective regulation transcend national borders and have global implications.

A recent WHO study provides one example of these problems, showing a high failure rate in quality control tests on chloroquine tablets in some sub-Saharan African countries (Figure 1). Only 58% of the medicines tested had an acceptable level of chloroquine content and only 25% had acceptable dissolution properties. The study authors suggest that poor quality chloroquine may be among the causes of the high rate of resistance in these countries. Treating patients with poor quality medicines results in low bio-availability and drug under-dosage, so promoting the development of resistance - one of the major threats to public health.

Figure 1. Percentage failures in ingredient content and dissolution in quality control tests on chloroquine tablets in seven sub-Saharan African countries

Source: The quality of antimalarials. A study in selected African countries. Geneva, World Health Organization; 2003.

In some countries, illegal manufacturing, distribution (including sales in market places and on streets) and smuggling of medicines are widespread. Even manufacturers who fail to comply with good manufacturing practice (GMP) requirements can still produce medicines for domestic use and for export. Often controls on exported medicines are less stringent than for those used domestically.

Figure 2. Reports of counterfeit medicines by therapeutic class received by WHO 1999-2002

Source: WHO Database on Counterfeit Medicines

Another major problem is that medicines are traded through several intermediaries and free-trade zones, and are sometimes repackaged and relabelled to hide their true source or identity, which can lead to the circulation of counterfeit medicines. Figure 2 gives the number of reports of counterfeit medicines, by therapeutic class, submitted to WHO from 1999 to 2002, and shows that the highest percentage concerned antibiotics.


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