Chapter 6: Pharmaceutical Legislation and Regulation

Abstract

6.2 6.1 The role of pharmaceutical legislation and regulation 6.2 Why pharmaceutical laws and regulations are necessary • Differences between pharmaceutical laws, regulations, and guidelines • Evolution of policy and law • Globalization and harmonization • Drafting and revising pharmaceutical legislation and regulations 6.2 Basic elements of national pharmaceutical legislation 6.7 6.3 Key provisions of national pharmaceutical legislation 6.7 Defining the roles of various parties • Licensing, inspection, and quality control • Pharmacovigilance • Advertising and promotion • Sanctions 6.4 Medicine registration, licensing, and marketing authorization 6.10