Essential Medicines and Biologicals
Medicines and Health Technologies
The Regional Network of National Laboratories for Quality Control of Vaccines was an initiative generated by the Regional System for Vaccines (SIREVA) in the Special Program for Vaccines and Immunization (SVI) of the Pan American Health Organization (PAHO). It is a strategy for development, production, and control of vaccines in the countries of Latin America and the Caribbean in order to promote access to quality vaccines in the Region.
In 1993, in Washington D.C., one of the objectives established by SIREVA was to provide the Region with a framework of action for implementation of a system that assures the quality of vaccines. Consequently, creation of a regional network for vaccine control was considered. This network would be made up of national control authorities and national control laboratories connected through a computer network. Its objectives would be as follows:
Harmonize protocols and methodologies.
Harmonize registration and licensing.
Develop and produce reference vaccines and standards.
Collaborative studies on new techniques.
Validate methodologies. Develop programs for certification of producers.
Accreditation program for national control laboratories.
Evaluate production protocols. Exchange and training programs.
Establish a post-marketing surveillance system.
Control the vaccines used in clinical research.
Maintain active links with the FDA/US, NIBSC/United Kingdom, Bureau of Biologics/Canada, and other regulatory entities.
In 1994, the First Meeting on Organization and Operationalization of the Regional Network of National Laboratories for Quality Control of Vaccines (RRLNCCV) was held in Chile with the participation of representatives from Argentina, Brazil, Chile, Colombia, Cuba, Ecuador, Mexico, and Venezuela. At this meeting different agreements related to the objectives indicated by SIREVA were established. A network technical committee (NTC) made up of 5 countries was created with SIREVA acting as secretariat of the committee.
The technical committee of the RRLNCCV met for the first time in Mexico in 1995. It was made up of Brazil, Cuba, Chile, Mexico, and Venezuela, with SIREVA as secretariat. At this meeting the responsibilities of the NTC were established and the following were approved:
1. General statutes of the RRLNCCV;
2. Guide for standardization of vaccines and reagents of regional reference; and
3. Protocols for collaborative studies on BCG, diphtheria antitoxin, tetanus antitoxin, and pertussis, as well as future collaborative studies and the principal investigators responsible for these studies.
From the time it was established up until 2008, Argentina, Brazil, Chile, Colombia, Cuba, Ecuador, Mexico, and Venezuela were active members of the Regional Network of National Laboratories for Quality Control of Vaccines (RRLNCCV). They performed many activities related to evaluation of the progress and difficulties of each collaborative study; establishment and distribution of regional standards; survey of information on the NRAs in the Region and their functions, as well as other activities.
Currently, the representatives of the Bolivarian Republic of Venezuela serve as coordinators of RRLNCCV activities.
The RRLNCCVs have changed some of their objectives, adapting them to the new realities. Some of the most recent results achieved by the work of this network have been:
Harmonization of laboratory tests for evaluation of vaccine quality.
Availability of regional reference standards regional reference standards for potency tests on the BCG, measles, pertussis, polio, and yellow fever vaccines, and the diphtheria and tetanus antitoxins. Moreover, identification of the needs of each country in this regard.
Establishment of software Establishment of software that facilitates uniform and harmonized preparation of quality control charts by the national laboratories for quality control of vaccines, including distance monitoring of development of the regional reference standards used and variations in the laboratory methods used.
Training for staff members of the countries that are members of the network on several subjects related to quality control of vaccines.
Promotion of rotation of experts from the national regulatory authorities and national laboratories for quality control of vaccines in PAHO/Washington.
Specific information from the agendas, pictures, minutes, and presentations made during the historical development can be found here here.