title: Regulatory framework for access to safe, effective quality medicines.
abstract: Medicines of uncertain quality, safety and efficacy can be worse than no treatment at all. It is the responsibility of national medicines regulatory authorities to protect patients from harm. Yet, there are great disparities in regulatory capacity globally, preventing large populations from accessing the benefits of advances in the pharmaceutical field. This article describes the main regulatory functions and how they are applied to assure the quality, safety and efficacy of different types of medicines in different environments. It gives examples of initiatives that have increased access to good quality medicines worldwide and - more importantly - are laying the groundwork for collaborative approaches aiming to ensure that pharmaceutical products meet the same, stringent quality standards in all parts of the world.
authors.affiliation: Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland. ragol@who.int.
authors.forename: Lembit
authors.initials: L
authors.lastname: Rägo
authors.forename: Hiiti
authors.initials: H
authors.lastname: Sillo
authors.forename: Ellen
authors.initials: E
authors.lastname: 't Hoen
authors.forename: Monika
authors.initials: M
authors.lastname: Zweygarth
mesh_terms: D019380:Anti-HIV Agents / Q000191:economics / Q000600:supply & distribution*; D023241:Antiretroviral Therapy, Highly Active; D058110:Counterfeit Drugs / Q000600:supply & distribution*; D017277:Drug Approval; D016568:Drugs, Generic / Q000191:economics / Q000600:supply & distribution*; D017408:Guidelines as Topic; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007391:International Cooperation; D016134:Organizational Policy; D011786:Quality Control; D013810:Therapeutic Equivalency; D014944:World Health Organization
chemical_list: D019380:Anti-HIV Agents; D058110:Counterfeit Drugs; D016568:Drugs, Generic