(2003; 6 pages) [French] [Spanish]
Regulation and quality assurance
The drug regulatory authority is the agency that develops and implements most of the legislation and regulations on pharmaceuticals, to ensure the quality, safety and efficacy of medicines, and the accuracy of product information. This is done by making certain that the manufacture, procurement, import, export, distribution, supply and sale of drugs, product promotion and advertising, and clinical trials are carried out according to specified standards.
Drug regulation is a complex task, with many stakeholders and vested interests involved. For this reason there are a number of basic requirements:
• Government commitment to drug regulation, including the need to ensure a sound legal basis and adequate human and financial resources;
• Independence of the regulatory authority to ensure that there is no conflict of interest;
• Commitment to good manufacturing practices, inspection and law enforcement;
• Regulation of traditional and herbal medicines;
• Ensuring adverse drug reaction monitoring systems;
• Commitment to regulation of information and drug promotion;
• International exchange of information.