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Understanding the licensing of medical products is fast becoming a requirement in clinical medicine. This text, written by specialists but tailored to the needs of the practising physician and pharmacist, explains the processes and regulations in the major drug producing countries. It should be useful to anyone prescribing, producing or working with medical products.
History of drug regulation in the UK.
Regulation of human medicinal products in the EuropeanUnion.
European regulation of medical devices.
The supply of unlicensed medicines for particular patientuse.
Controls on NHS medicines prescribing and expenditure in the UK(a historical perspective).
The regulation of therapeutic products in Australia.
Regulatory and clinical trial systems in Japan.
The regulation of drug products by the United States Food andDrug Administration.
The US FDA in the drug development, evaluation, and approvalprocess.
Technical requirements for registration of pharmaceuticals forhuman use: the ICH process and the Common Technical Document.
Appendix: European guidelines relevant for pharmaceuticalphysicians.