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CLINICAL PHARMACOLOGY 2003 (PART 7)

This chapter describes the background to why it became necessary to regulate the use and supply of drugs, and the ways in which these processes are managed. • Basis for regulation: safety, efficacy, quality, supply • Present medicines regulatory system • Present day requirements • Counterfeit drugs • Appendix: the thalidomide disaster change the safety information e.g. add new warnings, or contraindications. The quality aspects may also need to be revised as manufacturing practices change. MAH's have strong profit motives for making claims about their drugs. Only governments can provide the assurance about all those aspects in the life of. | 5 SECTION I Official regulation of medicines SYNOPSIS This chapter describes the background to why it became necessary to regulate the use and supply of drugs and the ways in which these processes are managed. Basis for regulation safety efficacy quality supply Present medicines regulatory system Present day requirements Counterfeit drugs Appendix the thalidomide disaster Basis for regulation Neither patients nor doctors are in a position to decide for themselves across the range of medicines that they use which ones are pure and stable and effective and safe. They need assurance that the medicines they are offered fulfil these requirements and are supported by information that permits optimal use. The information about and the usage of medicines gets out of date and there is an obligation on licence holders continually to review their licence with particular regard to safety. Marketing Authorisation Holders MAH i.e. pharmaceutical companies can also change the efficacy claims to their licence e.g. new indications extension of age groups or change the safety information e.g. add new warnings or contraindications. The quality aspects may also need to be revised as manufacturing practices change. MAH s have strong profit motives for making claims about their drugs. Only governments can provide the assurance about all those aspects in the life of a medicine in so far as it can be provided . The principles of official statutory medicines regulation are that No medicines shall be marketed without prior licensing by the government. A licence shall be granted on the basis of scientific evaluation1 of safety in relation to its use evaluation at the point of marketing is provisional in the sense that it is followed in the community by a pharmacovigilance programme efficacy now often including quality of life quality i.e. purity stability shelf-life 1 Except in the case of traditional herbal medicines which can be ineffective and or hazardous as well as other substances used