The World Health Organization and
pharmaceutical experts have recommended that Generic Drug
Policies be implemented to improve the availability of
affordable medicines. This document reports on the status of
generic drug policies in Latin America. The data presented
are based on several sources: a survey conducted in 2003,
archival information, and official health and pharmaceutical
policy documents. The survey revealed that countries use
different definitions for the terms generic and
bioequivalence severely curtailing the ability to make
comparisons across countries. There is also ample
variability in the periods allowed for drug registration and
registration charges. Although most countries in the region
are becoming increasingly dependent on pharmaceutical
imports, many have sizeable local pharmaceutical
manufacturing capacity. The need to adopt common definitions
for technical terms, the urgency of improving quality
controls and the importance of strengthening generic drug
programs are highlighted.
Bibliographic Details
| Main Authors: |
Homedes, Núria,
López Linares, Roberto,
Ugalde, Antonio |
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| Language: | English
en_US |
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| Published: |
World Bank, Washington, DC
2005-03
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| Subjects: | ACCESS TO PHARMACEUTICALS,
ACTIVE INGREDIENTS,
BIOEQUIVALENCE,
BRAND NAME,
BRAND NAME DRUGS,
BRAND NAMES,
BRANDED GENERIC DRUGS,
CLINICAL TRIALS,
COMMERCIALIZATION,
COUNTERFEIT DRUGS,
DRUG MANUFACTURING,
DRUG POLICIES,
DRUG POLICY,
DRUG PRICES,
ESSENTIAL DRUGS,
GENERIC DRUGS,
GENERIC PRODUCTS,
GENERIC SUBSTITUTION,
GMP,
GOOD MANUFACTURING PRACTICES,
HEALTH CARE,
HEALTH POLICY,
HEALTH SERVICES,
HOSPITALS,
HUMAN DEVELOPMENT,
LABORATORIES,
LATIN AMERICAN,
LAWS,
LOCAL PRODUCTION,
MARKET VALUE,
MEDICINE,
MEDICINES,
NATIONAL DRUG POLICIES,
NEW PRODUCT DEVELOPMENT,
NUTRITION,
PATIENTS,
PHARMACEUTICAL INDUSTRY,
PHARMACEUTICAL MANUFACTURING,
PHARMACEUTICAL POLICIES,
PHARMACEUTICAL POLICY,
PHARMACEUTICAL PRODUCTION,
PHARMACEUTICAL PRODUCTS,
PHARMACEUTICAL REGISTRATION,
PHARMACEUTICALS,
PHARMACISTS,
PHARMACOLOGY,
PHARMACY,
PHYSICIANS,
POLICY DOCUMENTS,
PRESCRIPTIONS,
PRICE CONTROLS,
PRIVATE SECTOR,
PROCUREMENT,
PUBLIC HEALTH,
PUBLIC SECTOR,
QUALITY,
QUALITY ASSURANCE,
RETAIL,
SAFETY,
SALES,
STRATEGIC PLANNING,
SUPPLIERS, |
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| Online Access: | http://documents.worldbank.org/curated/en/2005/03/5734957/generic-drug-policies-latin-america
https://hdl.handle.net/10986/13639
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