Quality Control of Medicines

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.
• One priority of the network is to monitor ESAVI related to the introduction of rotavirus vaccines and determine the magnitude and profile of adverse events, including rare events.
• Set up a reliable system capable of identifying potential risks early on and sharing the information efficiently and in a timely manner.
• Develop a rapid alert system for reporting severe and unanticipated cases (do not include mild and moderate events). A list will be drawn up of known events to report.
• Issue recommendations for corrective measures as serious and/or unanticipated events are identified and verified. Provide documentation that the vaccine is not a risk factor for intestinal invagination in the reported cases. Make efforts in the medium term to monitor the effectiveness of the new vaccines.
• Support other countries that introduce the vaccines under network surveillance.
• Boost surveillance capacity at the national, regional and global levels, reinforcing the complementarity of roles between the EPI and the NRA.
• The network should cover the distribution and uses of the vaccines in both the public and private sectors. Harmonize definitions (glossary).

Implementation of the Network:

• All entities involved in vaccine surveillance will participate at the country level. These institutions should interact and collaborate to reach a consensus on conclusions. There should be a commitment to coordination among the various participants.
• The countries should name a focal point for reporting adverse events to the network, in keeping with the roles established in the system of their respective countries.
• It is proposed that the reporting mechanism be the same one established and used to notify the Uppsala Center.
• The member countries commit to maintaining timely and regular communication. The measures to adopt on the basis of the network's findings will be communicated and shared.
• The member countries commit to sending the data from adverse event reports on a regular basis as a condition for retaining their membership. The reports should be sent monthly to PAHO by the fifth business day of the month.
• Pursuant to the official procedures, PAHO will send the countries the report from the meeting through official channels, formally requesting that they specify the institution responsible for reporting the data to the network.
• The institution or focal point will send the network the data obtained through the surveillance system established and the information on producers provided by the surveillance system, taking care beforehand not to duplicate the data.
• Other countries may participate in the network of sentinel countries at their request or that of countries that are already members. The new members should meet technical requirements that guarantee a contribution to the network and have an operational surveillance system at the country level.
• SANEVA (safety of new vaccines) is suggested as the name for the network of sentinel countries.

Virtual Health Library - Search by Subjects Related to Essential Medicines and Biologicals. Sources - Database: General Health Science: LILACS, MEDLINE /International Agencies: PAHO-Pan American Health Organization, WHOLIS-World Health Organization / Cochrane Library: Cochrane systematic reviews, Protocols of Cochrane systematic reviews, CENTRAL, Abstracts by INAHTA, economic studies and critically appraised, abstracts of quality assessments / BBO-Brazilian Dentistry Bibliography  / MEDCARIB-Caribbean Health Sciences Literature / Bandolier / Ibero-American Clinical Trials, Evidence. Updating in ambulatory, Reports / HIL-Internet Resources.

Access and Innovation

• Medicines Access
• Innovation and medicines 
• Diffusion of Innovation 
• Diffusion Innovation and Medicines 
• Drug Industry 
• Drug Industry and Innovation  
• Drug Industry/trends 
• Drugs Cost 
• Medication Systems 

Intellectual Properties

• Intellectual Property 
• Patents as Topic and Pharmaceutical Preparations 

Pharmaceutical Policies

• Pharmaceutical policy  
• Drugs Generic 
• Drugs, Essential   
• Health Policy and Drugs 
• Legislation, Drug 
• Legislation, Pharmacy 

Quality and Regulation

• Drug Quality and Regulation 
• Drug Quality 
• Drug Quality and Regulation 
• Medicine Package Inserts   
• Pharmaceutical Preparations 
• Pharmaceutical Services   
• Prescriptions, Drug- /standards 
• Product Surveillance, Post marketing 
• Drug Approval 
• Drug Contamination 

Vaccines and Biologicals

• Vaccines and Biological 

Rational Use

• Drugs Rational Use 
• Drug Evaluation  
• Drug Information Services 
• Drug Labeling  

Workshop for the Implementation of Control Charts in Vaccine Quality Control

The Workshop for the Implementation of SPC Explorer RT Software for the Management of Control Charts in Vaccines Quality Control Laboratories was held in Río de Janeiro, Brazil, 16 - 19 June, 2008. The general objective of the workshop was to implement the software SPC Explorer RT and to summarize the performance analysis of potency tests of standards.

–   pdfList of participants (31.73 kb pdf, in Spanish)

–   pdfSummary (31.48 kb pdf, in Spanish)

The specific objectives were as follows:

To teach the countries basic statistical knowledge for the analysis of vaccine quality control charts To familiarize the countries with statistical process control software, SPC Explorer RT To translate the results of potency values of standards used in the quality control of vaccines of the countries into SPC graphs.

To distribute SPC Explorer RT licenses for statistical analysis of vaccine quality control charts to the participants of the vaccine control laboratories. In conclusion, the countries' participants gained basic statistical knowledge for the purpose of vaccine quality control charts.

More specifically, they were taught the analysis of vaccine quality control charts by using the statistical process control software, SPC Explorer RT. Moreover, the countries were then able to make potency testing graphs on location. Finally, every country took one license of the software to their laboratory and has the opportunity to familiarize itself with the broad applications of the software.

This space has been designed with the main objective of keeping the information on the activities carried out by the Regional Network of National Vaccine Quality Control Laboratories (RRLNCCV). The agendas, minutes, photos, and presentations from the meetings and/or workshops held during the development of this Network can be found below.

May 1997: Washington, D.C., U.S.A.   pdf 

• Minutes (Spanish)

June 1997: Havana, Cuba 

•  pdfMinutes (Spanish)

February 2004: Rio de Janeiro, Brazil

• Minutes:Workshop on harmonization of the potency tests for diphtheria and tetanus toxoids
• Annex 1: Summary of tests used by the laboratory associated with the ANC to measure the potency of tetanus and diphtheria toxoids
• Annex 2:Work plans

March 2005: Caracas, Venezuela  

•  pdfMinutes (Spanish)
• Presentations (  pdfP. Parreiras ;  pdfJ. Arciniega ;  pdfM. Cortés ;  pdfM. Ibarz Background;  pdfM. Ibarz ;  pdfM. Pombo )

June 2006: Caracas, Venezuela (PAHO/WHO international training course on rotavirus vaccine potency tests):   

•  pdfList of participants
• Presentations (  pdfZ. Arvelo ;   pdfA. Agaton ;  pdfA. Palacios ;  pdfC. Gutierrez ;  pdfG. Waeterloos ;  pdfL. Brito ;  pdfM. Ibarz ;  pdfM. Pombo ;  pdfP Minor )

November 2006: Rio de Janeiro, Brazil

•  pdfMinutes  (Spanish)  
• Presentations (  pdfM. Pombo ;  pdfE.Leal ;  pdfM. Ibarz ;  pdfF. Fuchs )

March 2009: Panama, Panama 

•  pdfAgenda
•  pdfMinutes
• Annexes:  pdfInventario y necesidades de patrones regionales/país

• Presentations:  pdfM. Cortés ;  pdfM. Pombo ;  pdfA. Martinez ;  pdfA. Lara ;  pdfCCAYAC-Mexico ; and 3 presentations by M. Corbel (  pdfReferences ,  pdfRegional PER-02 , y  pdf2nd-Standards )

2012: Ottawa, Canada (Spanish)

•  pdfAgenda 
•  pdfIntroduction
•  pdfSituation of RRLNCCV
•  pdfMinutes 

Assessment of national regulatory authorities for medicines

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 regulatory bodies.

The assessment of NRAs is based on the fulfillment of critical indicators (46% of the indicators in the data collection tool). Four levels of development have been established. Level 4 is the level that enables PAHO to designate the regulatory body as a reference authority for medicines and biologicals.

Designation of the regional reference NRA is the responsibility of the regulatory authorities that reach level 4 of the assessment table.

Level 4: National regulatory authority that is competent and efficient in the performance of the health regulation functions recommended by PAHO/WHO to guarantee the efficacy, safety, and quality of medicines. REGIONAL REFERENCE AUTHORITY.

Objectives and scope of a regional reference NRA

a) Participate in the quality assurance, safety, and efficacy processes for the products purchased by the Pan American Health Organization on behalf of the countries.

b) Collaborate as referents in the implementation and follow-up of recommendations approved by the PARF network.

c) Support the Pan American Health Organization in the strengthening activities for other national regulatory authorities in the Region, so that they can be designated as regional reference regulatory authorities.

d) Exchange public information through its Web sites and in the framework of the current national legislation on the products approved by the regional reference regulatory authorities. This will enable authorities with more limited capacities to have elements available for decision-making about their own products, considering that the products registered and sold in the countries with regional reference regulatory authorities will fulfill the quality standards recommended by WHO.

e) Establish mechanisms in agreement with the Pan American Health Organization that can favor the mutual recognition processes for the functions of the pharmaceutical regulatory bodies.

More information: 

WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products - Revision VI

A Framework for evaluating and publicly designating regulatory authorities as WLA
WHO-Listed Authority (WLA) 

Convocation of experts in NRA

The experts will be resources of the system for evaluation of national reference regulatory authorities and the system for the prequalification of medicines. It is developed to:

• Establish a transparent mechanism for the selection of experts that participate in an evaluation of NRAs in accordance with the criteria established and shared by the countries of the region and approved by PAHO.
• Form evaluation teams of the highest professional level to ensure standard development of the evaluations, yielding reliable and validated results.

Procedure for selection of experts

• Presentation and reception of background information on the applicants. The reception date will be prior to the final day of February each year.
• Review and evaluation of the background information. The background information and documents for the applicants will be evaluated in March each year.
• Final report: Within the first 7 days of April a report will be sent to WHO, the regional offices, and the national regulatory authorities of the Region of the Americas making known the list of PAHO advisory experts in the area of regulation of medicines. An updated list will also be maintained on the PAHO Web site.

Results of the assessment

Level 4 National regulatory authority that is competent and efficient in the performance of the health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines. Regional reference authority.

Level 3 National regulatory authority that is competent and efficient, which shall improve the performance of certain health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines.

Level 2 Structures or organizations with the mandate of the national regulatory authority that fulfill certain health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines.

Level 1 Offices of health institutions that fulfill certain health regulation functions for medicines. 

Regional Reference Authorities for medicines CD50.R9 (January, 2018)

• Argentina ANMAT. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
• Brazil ANVISA. Agencia Nacional de Vigilancia Sanitaria. Ministério da Saúde
• Canada HS - Health Canada
• Chile ISP, Instituto de Salud Pública
• Colombia INVIMA - Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Cuba CECMED, Centro para el Control Estatal de la Calidad de los Medicamentos.Ministerio de Salud Pública
• Mexico COFEPRIS, Comisión Federal para la Protección contra Riesgos Sanitarios
• United States of America USFDA - Food and Drug Administration

National Regulatory Systems for Medicines in The Americas. Evaluation and Pre-evaluation - CD50.R9 (January, 2018)

 Country, Institution and (Year)

• Argentina ANMAT. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (2017)
• Bahamas BNDA - Bahamas National Drug Agency (2017)
• Barbados BDS - Barbados Drug Service (2015)
• Bolivia UNIMED, Unidad de Medicamentos y Tecnologías de la Salud (2009)
• Brazil ANVISA. Agencia Nacional de Vigilancia Sanitaria. Ministério da Saúde (2017)
• Canada HC - Health Canada (2015)
• Chile ISP - Instituto de Salud Pública (2016)
• Colombia INVIMA - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (2017)
• Costa Rica Dirección General de Salud/Universidad/Caja Costarricense del Seguro Social (2011)
• Cuba CECMED - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (2017)
• Dominican Republic Dirección General de Drogas y Farmacia (2011)
• Ecuador Instituto Nacional de Higiene y Medicina Tropical "Leopoldo Izquieta Pérez". Ministerio de Salud (2017)
• El Salvador Dirección Nacional de Medicamentos (2017)
• Guatemala Departamento de Regulación y Control de Productos Farmacéuticos y Afines (2010)
• Guyana FDD - Food and Drug Department (2013)
• Haiti DNM/MT - Direction de la Pharmacie, du Médicament et de la Médecine Traditionnelle (2017)
• Honduras Secretaría de Salud/Dirección General de Regulación Sanitaria (2011)
• Jamaica DSR - División de Estandarización y Regulación (2013)
• Mexico COFEPRIS - Comisión Federal para la Protección contra Riesgos Sanitarios (2017)
• Panama Dirección de Drogas y Farmacia (2011)
• Paraguay Dirección Nacional de Vigilancia Sanitaria (2016)
• Peru DIGEMID, Dirección General de Medicamentos, Insumos y Drogas (2013)
• Suriname Autoridad Reguladora Nacional (2013)
• Trinidad and Tobago Autoridad Reguladora Nacional (2011)
• United States of America USFDA - Food and Drug Administration (2016
• Venezuela IHRR, Instituto Nacional de Higiene Rafael Rangel(2013)

Presentation:Strengthening the National Regulatory Authorities (José Peña) (only in Spanish)

 Results of the evaluation system

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 the 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, the 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.

Objectives

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 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 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.

PAHO/WHO meeting to review the regulation of vaccines and drugs for responding to Pandemic Influenza H1N1

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 meeting was attended by representatives of the NRA of Argentina, Brazil, Canada, Chile, Colombia, Cuba, the United States, Peru, Paraguay, and Uruguay.

All the information on this event can be found below:

• Agenda (Spanish)
• Presentations (M. Cortes; C. Alfonso; D. Pfeifer & C. Alfonso)

Reference documents:

• WHO Guideline on Regulatory Preparedness for Human Pandemic Influenza Vaccines, October 2007.
• Update of WHO biosafety risk assessment and guidelines for the production and quality control of human influenza pandemic vaccines. May 2009 
•  pdfWHO biosafety risk assessment and guidelines for the production and quality control of human influenza pandemic vaccines: Update. July 2009.

• Conclusions of the meeting (in Spanish)

II Workshop on Medicines Regulation in the Caribbean, Barbados, September 8-9, 2009

"Strengthening of National Medicines Regulation Authorities"

• (Download Final Report)

Main Objective:

• To strengthen mechanisms of collaboration and harmonization of regulation of medicines in the Caribbean

Specific Objectives:

-To establish priorities and to design strategies for strengthening and harmonizing the regulation of medicines in the Caribbean in the context of the essential public health functions,
-To share the outcomes of surveys related to the pharmaceutical situation and the assessment of national regulatory authorities in the Caribbean;
-To design and discuss mechanisms of communication and collaboration among regulatory authorities.
-To identify the possible common legal framework, guidelines and technical documents for strengthening essential regulatory functions;
-To discuss possibilities of strengthening the Human Resource capacity for regulation of medicines.

Participants:

14 Caribbean countries, Organization of Eastern Caribbean States Pharmaceutical Procurement Service (OECS/PPS) and experts from SECMED (Cuba), National Medicines, Food and Medical Technology Authority (ANMAT-Argentina), The National Health Surveillance Agency (ANVISA-Brasil) and The US Food and Drug Administration (FDA-United States).

Presentations:

• Regulatory Function of Drug Registration(Dr. Celeste Sánchez González)
• Strengthening the National Regulatory Authorities and the Essential Regulatory Functions (Dr. Adriana Mitsue Ivama)
• Pharmaceutical Situation (Dr. Adriana Mistue Ivama)
• The Regulatory dimension as an Essential Public Health Function (Dr. Gabriel Vivas)
• Current Status of Pan American Network for Drug Regulatory Harmonization (PANDRH) (Dr. James Fitzgerald)
• Essential Regulatory Functions: Quality Assurance The CRDTL Experience (Dr. Lucette Cargill)
• Experiences on harmonization and mechanisms of sub-regional integration

The Medicines and Health Technologies project (HSS/MT) of PAHO hosted a meeting entitled "Regional meeting on the regulation of biotechnological products - First meeting of the biological/biotechnological products PANDRH working group" in Punta Cana, the 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.

Regulation of biotechnological products Regional Meeting

The Pan American Health Organization, PAHO, through the Medicines and Health Technologies project, of the Area of Health Systems based on Primary Health Care (HSS/MT), 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. A group of professionals representing Argentina, Barbados, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Germany, Guatemala, Peru. Spain, Trinidad & Tobago, and the United States of America have participated, as well as representatives from the World Health Organization (WHO), and the PAHO. 

The meeting aims were to present the current situation of biotechnological products regulation among countries (during the first two days) and to establish the objectives, responsibilities, and plan of actions of the Pan American Network on Drug Regulatory Harmonization (PANDRH) working group of biological/biotechnological products at the third day of the meeting.

All information generated by the BIO Working Group will be posted on the PANDRH website. It will include the working group mission, objectives, members, and recommendations, as well as other related documents.

•  pdfPANDRH Statutes (309.58 kB)
•  pdfList of Participants (54.84 kB)

Presentations:

Day 1:

• Objectives and logistics. María L. Pombo. PAHO
• Pan American network on drug regulatory harmonization (PANDRH): history, objectives, recent activities and group's conformation. José Peña. PAHO
• WHO Guidelines on evaluation of similar biotherapeutic products (SBPs), adopted by the Expert Committee on Biological Standardization (ECBS). Ivana Knezevick. WHO
• ICDRA recommendations: Emerging regulatory issues concerning biosimilars and biologicals. Ivana Knezevick. WHO
• Similar biological medicinal products regulation - Quality aspects to be considered - EMEA Perspective, and Spanish experience on product's substitution and its traceability. Sol Ruiz. Agencia Española de Medicamentos y Productos Sanitarios
• Cuban regulation for biotechnological and biosimilar products. Post-marketing surveillance measures. Olga L. Jacobo. CECMED
• Advances, objectives and challenges on the harmonization of biotechnological products regulation. Issues identifying and actions by MERCOSUR. Patricia Aprea. ANMAT

Day 2:

• What is happening where biosimilars are currently available? The case of Latin America. Rafael Alfonso. University of Washington, RANDOM Fundation
• Reference products and extrapolation of indications guidance for Subsequent Entry Biologics (SEBs) -Canadian Experience. Elwyn Griffiths. Health Canada
• Non-clinical and clinical guidance for similar biological medicinal products EMEA Experiences. Michael Pfleiderer. Paul Ehrlich Institute
• Situation in selected countries of similar biotherapeutic products regulation. Ivana Knezevick. WHO
• Presentations of NRA invited: local advances and challenges in the area of regulation of biotechnological products: Argentina (Patricia Aprea), Brasil (Marcelo Matos), Colombia (Patricia Carmona), Chile (Eduardo Johnson), Peru (Hans Vasquez)

Day 3:

• BIO working group objectives. María L. Pombo. PAHO
•  pdfBiotechnological Products Working Group Report. PANDRH. 17 Jun 2010    Dominican Republic. 15 17 Jun 2010.

(The following information is available only in Spanish)

Reunión de Autoridades Nacionales Reguladoras de Productos Biológicos en Latino América y el Caribe "Productos Biológicos / Biotecnológicos".

República Dominicana 12 y 13 de junio de 2008.

La Organización Panamericana de la Salud (OPS), a través del Proyecto de Medicamentos Esenciales y Vacunas, del Área de Tecnologías, Salud e Investigación, llevó a cabo la primera reunión de autoridades nacionales reguladoras, denominada "Regulación de Productos Biológicos / Biotecnológicos en Latino América y el Caribe", en República Dominicana, del 12 al 13 de junio de 2008. Dicha reunión contó con la participación de un total de 16 países (República Argentina, Bolivia, Brasil, Canadá, Chile, Colombia, Costa Rica, Cuba, Ecuador, Guatemala, México, Nicaragua, Panamá, Perú, República Dominicana y República Bolivariana de Venezuela), los cuales, tuvieron la oportunidad de presentar su regulación actual para este tipo de productos, que incluye procedimientos establecidos para el registro, documentos solicitados durante dicho procedimiento.

Objetivos de la reunión

Mostrar los resultados del diagnóstico realizado por la OPS, sobre la regulación de productos biológicos/biotecnológicos en Latino América y el Caribe, en el cual participaron 17 países, y conocer las diferencias existentes en las regulaciones actuales, así como también, las fortalezas y/o debilidades existentes en la Región en materia regulatoria de productos biotecnológicos, con miras a ofrecer soporte técnico que permita elaborar procedimientos, guías y documentos armonizados relacionados con este tema.

Documentos

•  pdfMinuta de la Reunión de Autoridades Nacionales Reguladoras de Productos Biológicos 2008 (39.05 kB)
•  pdfAgenda. Reunión de Autoridades Reguladoras de Productos Biológicos en Latino América y el Caribe. (40.51 kB)
•  pdfContactos para la regulación de productos biológicos o biotecnológicos (50.33 kB)
•  pdfLista de participantes. Reunión de Autoridades Nacionales Reguladoras (44.21 kB)

Presentaciones

•  pdfIntroducción a la Reunión. Ma. de los Angeles Cortés. OPS. Asesora Regional en Vacunas y Biológicos (465.03 kB)
•  pdfDiagnóstico. María L. Pombo (199.94 kB)
•  pdfDocumentos de Referencia Disponibles en la Regulación de Productos Biológicos/Biotecnológicos (409.48 kB)
•  pdfRegulatory Evaluation of Biosimilars / Subsequent Entry Biologicals. Elwyn Griffiths. Canada (201.27 kB)
•  pdfReunión de Trabajo OMS sobre Regulación de Productos Biológicos terapéuticos, Seul, 2008. María L. Pombo y Elwyn Griffths (116.13 kB)