Medicines and the New Economic Environment
(1998; 252 pages) [Spanish]
Table des matières
Afficher le documentTHE AUTHORS
Afficher le documentPREFACE
Afficher le documentINTRODUCTION
Ouvrir ce répertoire et afficher son contenuI. THE GLOBAL ECONOMIC ENVIRONMENT
Fermer ce répertoireII. THE REFORM OF HEALTH CARE SYSTEMS
Ouvrir ce répertoire et afficher son contenuII. 1. Cost Containment and Health care Reforms: the Impact on Pharmaceuticals
Ouvrir ce répertoire et afficher son contenuII.2. Reform of Health Care Services in Developing Countries, Role of the State and Essential Drugs
Fermer ce répertoireII.3. Regulation, Policies and Essential Drugs
Ouvrir ce répertoire et afficher son contenu1. TWO MAJOR TRENDS
Fermer ce répertoire2. DRUGS
Ouvrir ce répertoire et afficher son contenu2.1. The process of innovation
Ouvrir ce répertoire et afficher son contenu2.2. The selection process
Ouvrir ce répertoire et afficher son contenu2.3. The expansion of markets
Ouvrir ce répertoire et afficher son contenu2.4. The creation of common areas: harmonization
Fermer ce répertoire2.5. Ongoing processes
Afficher le document2.5.1. World Health Organization
Afficher le document2.5.2. The International Conference for Drug Regulatory Authorities
Afficher le document2.5.3. The International Conference on the Harmonization of Technical Requirements for the approval of medicinal products for humans (ICH)
Afficher le document2.5.4. The European Community
Afficher le document2.5.5. The Andean group
Afficher le document2.5.6. Mercosur
Afficher le document2.5.7. Central America
Afficher le document3. CONCLUSIONS
Ouvrir ce répertoire et afficher son contenuIII. A CHANGING PHARMACEUTICAL INDUSTRY
Ouvrir ce répertoire et afficher son contenuIV. SYNTHESIS AND FORECASTS
Afficher le documentBIBLIOTECA CIVITAS ECONOMÍA Y EMPRESA
Afficher le documentBACK COVER
 
2.5.7. Central America

The process in Central America has had certain similarities with the Andean Group, but with greater emphasis on the Harmonization of Pharmacological Standards. It has given much relevance to the strengthening of control and quality assurance mechanisms establishing, amongst others, a network of testing laboratories.

GMPs from the World Health Organization have also been adopted in the Central American sub-region, and the countries have initiated a process which is aimed to their affiliation to the WHO Certification System for products under International Trade.

Intensive work has been carried out to improve the information systems related to regulatory approval and its computerization, as grounds for decision-making. The core of the harmonizing principles for the management of Regulatory Approvals appears to be very promising, particularly since common principles for the Cosmetics Approval have been established, based on the adoption of common lists, both positive and negative, i.e. active and inert substances that are allowed and prohibited in each cosmetic line.

A code for the Promotion of Drugs has also been drafted, following the basic principles of WHO guidelines on the subject.

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Dernière mise à jour: le 3 mai 2013