Essential medicines and health products

What should be done to ensure the safety, efficacy and quality of medicines?

Governments must regulate the manufacture, export, import, storage, distribution, supply and sale of medicines to ensure the safety, efficacy and quality of medicines.

Governments have to establish strong national medicines regulatory authorities (NMRAs). To enable the NMRAs to operate effectively, governments have to provide strong political support, adequate and sustainable human, financial and other resources, and legal power for enforcement. Ineffective regulation and control can result in the proliferation of unsafe, ineffective, substandard and counterfeit medicines.

In addition, manufacturers have to produce medicines in accordance with good manufacturing practice (GMP) requirements and distributors have to store and distribute medicines in accordance with good storage and good distribution practices as provided in the WHO guidelines (Guide to good storage practices for pharmaceuticals,) Annex 9, WHO Technical Report Series 908, 2003: Good distribution practices for pharmaceutical products, Annex 5, WHO Technical Report Series 937, 2006: