FRONTESPIZIO - Cooperazione Italiana allo Sviluppo

84 Andrea Gardellin, Abraham Gebre Giorgis2. Legislation and Regulation2.1 Why is this important?A legislative framework is required to implement and enforce policies regulatingthe pharmaceutical sector. Laws and regulations create a legal basis forthe control of activities in the public and private pharmaceutical sectors, includingadministrative measures and sanctions in response to violations.Areas covered include the roles and responsibilities of the drug regulatory authority;market approval and registration of medicines; regulation of premiseswhere medicines can be handled; and the qualifications, rights, and responsibilitiesof drug manufacturers, importers, exporters, distributors, prescribesand dispensers. Other key regulatory issues include implementationof policies on generic products to ensure the availability and use of lowerpricedmedicines, and monitoring of adverse drug reactions (ADRs) to productson the market. The regulatory authority must ensure that only safe, effective,high quality medicines are produced, marketed, prescribed and dispensedto protect and promote public health.2.2 What is the current situation?Table 2. Presence of key pharmaceutical sector legislation∞∞The majority of countries have established a drug regulatory agency.Countries • The majority at all income of countries levelshave report established the presence a drug of regulatory extensive agency. legal and regulatoryframeworks • Countries covering at all all income aspects levels of the report pharmaceutical the presence sector. of extensive legal and regulatoryframeworks covering all aspects of the pharmaceutical sector.Table 3. Legislation and regulation on registration of medicines