(1997; 248 pages) [French]
2.1 Legal base
Drug quality assessment and assurance should have an adequate legal framework forming an integral part of general drug legislation. All regulatory and technical elements of quality assessment and assurance require the provision of legal powers to undertake these activities and to prescribe norms. The enabling legislation should provide the necessary authority to develop particular regulations in connexion with quality assurance during the manufacture, importation and distribution of pharmaceutical products and, in some cases, pharmaceutical raw materials. Additional regulations governing the practice of pharmacy, which form part of health legislation, may also be relevant here.
The responsibility for the development of guides, norms, and administrative regulations may frequently be assigned to a drug control agency. Wide differences in legal approaches exist between countries according to whether the administrative structure is centralized or decentralized. It is, however, possible in the case of a decentralized system to establish legislation that permits the sharing of responsibility, and the coordination of all activities in the quality assessment of pharmaceutical supply systems.