Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Close this folderAntimicrobial resistance - new initiatives
View the documentWHO’s global strategy for the containment of antimicrobial resistance
View the documentImplementing a strategy for the containment of antimicrobial resistance: experience in Uganda
View the documentVeterinary issues contributing to antimicrobial resistance
View the documentStatus of regulation of antimicrobials in Cuba
View the documentFighting antibiotic resistance in Sweden
View the documentAntimicrobial use in Chile - the impact of regulatory measures
View the documentRecommendations
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Status of regulation of antimicrobials in Cuba

Dr Rafael Perez Cristia, Cuba

Resistance to antibiotics, and the consequent reduction in their effectiveness in treating infections in humans, constitute a growing problem throughout the world. In order to tackle antimicrobial resistance, the Ministry of Public Health and the National Regulatory Authority in Cuba established an action plan to promote the rational use of antibiotics and adopted strict legislation governing the registration, prescription and use of antibiotics. This plan is in line with the recommendations of World Health Assembly Resolution WHA 51.17, the Pan American Conference on Antimicrobial Resistance in the Americas, and the Guadalajara Declaration to Combat Antimicrobial Resistance in Latin America.

All health institutions, including hospitals and community centres, are involved in the National Programme for Monitoring and Surveillance of Antimicrobial Resistance. This Programme is coordinated by the Institute of Tropical Medicine “Pedro Kuory” in Havana with the participation of the National Network of Microbiological Laboratories.

The main regulations for antibiotic use in Cuba include:

• legislation that establishes the list of antibiotics that can be used only in hospitals and those allowed to be dispensed in community pharmacies,

• sale of antibiotics on medical prescription only,

• establishment of infection control committees responsible for epidemiological surveillance of antimicrobial resistance, and

• establishment of pharmacotherapeutic committees responsible for policies on antibiotic use in each hospital.


The Cuban regulatory authorities also require that data on antimicrobial resistance should be part of any application for approval of a new antibiotic.

The Cuban authorities know that this problem needs to be treated locally, according to the nature and evolution of antimicrobial resistance in the country. Health policies need to promote a better understanding of all aspects related to combating antimicrobial resistance, including intensive surveillance and the rational use of antibiotics.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: August 29, 2014