1. Medicines regulation - ensuring effective medicines with acceptable risk

Medicines regulation incorporates several mutually reinforcing activities all aimed at promoting and protecting public health. These activities vary from country to country in scope and implementation, but generally include the following:

• Assessing the safety, efficacy and quality of medicines, and issuing marketing authorisation for individual products

• Licensing of the manufacture, import, export, distribution, promotion and advertising of medicines

• Inspecting and surveillance of manufacturers, importers, wholesalers and dispensers of medicine

• Controlling and monitoring the quality of medicines on the market

• Controlling promotion and advertising of medicines

• Monitoring safety of marketed medicines including collecting and analysing adverse reaction reports

• Providing independent information on medicines to professionals and the public