Medicines and Health Technologies
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Quality and Regulation of Medicines and Health Technologies
This section provides information on the technical cooperation activities conducted by PAHO in conjunction with the national regulatory authorities and the national control laboratories in the areas of regulation and control of medicines, including pharmaceutical products, vaccines, and other biologicals.
The external quality control program, developed by the Pan American Health Organization/World Health Organization (PAHO/WHO), evaluates the performance of the official laboratories for control of medicines. It has been active since December of 2001 with the assistance of The United States Pharmacopeia (USP).
The Official Medicines Control Laboratories (OMCL), in their status as entities assigned to the regulatory authorities, have been included in the PARF network since June 2005. At that time the Working Group on Good Laboratory Practice (WG/GLP) was created by recommendation of the Fourth Conference.
Participants: Argentina, Brazil, Mexico, Panama y Venezuela, PAHO/WHO. Objectives: Conduct post-marketing surveillance of adverse events supposedly attributable to vaccination or immunization associated with new vaccines introduced in the Region to collect data on their safety profile and act accordingly.
A collection of links to Virtual Health Library (VHL) searches (by subject) related to medicines and health technologies. Sources include multiple databases and internet resources.
The general objective of the workshop, held in Río de Janeiro, Brazil, 16-19 June, 2008, was to implement the software SPC Explorer RT and to summarize the performance analysis of potency tests of standards.
Information on the activities carried out by the Regional Network of National Vaccine Quality Control Laboratories (RRLNCCV): agendas, minutes, photos, and presentations from the meetings and/or workshops held during the development of this Network.
The process of evaluation and assessment of NRAs is based on verification of the indicators included in the data collection tool. This instrument is based on the recommendations of the World Health Organization for strengthening the regulatory bodies.
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.
As part of the activities to strengthen the national drug regulatory authorities (NRA), the Pan American Health Organization (PAHO), in conjunction with the World Health Organization (WHO), held this meeting in Buenos Aires, Argentina, from 1 to 3 December 2009. The main objective was to review regulatory aspects of the introduction of pandemic influenza A (H1N1) vaccines in the participating countries, in terms of: licensing, laboratory tests, and the monitoring of adverse events (in coordination with the Expanded Program on Immunization or the responsible officials of the respective Ministries of Health).
The II Workshop on Medicines Regulation in the Caribbean, "Strengthening of National Medicines Regulation Authorities," was held in Barbados on September 8-9, 2009, with it's main obective being to strengthen mechanisms of collaboration and harmonization of regulation of medicines in the Caribbean.
The Medicines and Health Technologies project (HSS/MT) of PAHO hosted a meeting entitled "Regional meeting on regulation of biotechnological products - First meeting of the biological/biotechnological products PANDRH working group" in Punta Cana, Dominican Republic on 15 - 17 June 2010. Health professionals from Argentina, Barbados, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Germany, Guatemala, Peru. Spain, Trinidad & Tobago, and the United States of America participated, as well as representatives from the World Health Organization (WHO) and PAHO.
A government, through the regulatory authority for medicines, which can be constituted as a regulatory agency or a regulatory body for medicines, establishes and maintains the rules, laws, and policies required to ensure that medicines (including pharmaceutical products, vaccines, and other biologicals) are safe and effective, and fulfill the quality specifications offered by the producer.