Drug Regulation: History, Present and Future. In: van Boxtel CJ, Santoso B, Edwards IR eds., Drug Benefits and Risks: International Textbook of Clinical Pharmacology, Revised 2nd Ed. (Chapter 6). IOS Press and Uppsala Monitoring Centre, 2008
(2008; 13 pages)


The use of ineffective, poor quality, harmful medicines can result in therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death. It also undermines confidence in health systems, health professionals, pharmaceutical manufacturers and distributors. Money spent on ineffective, unsafe and poor quality medicines is wasted – whether by patients/consumers or insurance schemes/governments. Governments have the responsibility to protect their citizens in the areas where the citizens themselves are not able to do so. Thus, Governments need to establish strong national regulatory authorities (NRAs), to ensure that the manufacture, trade and use of medicines are regulated effectively. In broad terms the mission of NRAs is to protect and promote public health.Medicines regulation demands the application of sound scientific (including but not limited to medical, pharmaceutical, biological and chemical) knowledge and specific technical skills, and operates within a legal framework. The basic elements of effective drug regulation have been laid down in several WHO documents...

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