1. Home
  2. The Pan American Network for Drug Regulatory Harmonization (PANDRH)
  3. PANDRH Technical Working Groups

PANDRH Technical Working Groups

The following information is presented as part of the history of the PANDRH working groups. The PANDRH Technical Working Groups system was switched in 2015 to a project- based approach in prioritized areas-the following is historical information

2015 [Terms of Reference. Procedure for the Prioritization of Areas and Selection of Projects PANDRH]

The Working Group system switched to a project-based approach in priority areas in 2015. For updated information on the Pan American Network for Drug Regulatory Harmonization (PANDRH) visit the website. 

 

PANDRH Technical Working Groups (historical records)

PANDRH Technical Working Groups

PANDRH Working Groups consist of groups of experts in areas that have been identified as priorities for drug regulatory harmonization. Members are selected by the steering committee and confirmed by the regulatory authorities of the respective countries. Whenever possible, working groups have at least one representative from each of the five sub-regional blocs of the Americas.

Academics and other experts can be members of the working groups. Each group's main objectives include the implementation of diagnostic studies to identify the differences among the countries regarding the implementation of international standards and to define the necessary strategies for technical cooperation, analyze international guidelines, and prepare harmonized proposals in their areas to be considered during the conference for implementation in the region. PANDRH rules and regulations (available only in Spanish) have a specific chapter on Working Groups operation; also available: the member list of the technical working groups (2010).

 

Grupo de trabajo de vacunas (información histórica)
La misión del grupo de trabajo de vacunas es la de promover la armonización de la reglamentación farmacéutica para las vacunas con vistas a garantizar su calidad, seguridad y eficacia, generando mecanismos mas eficientes que contribuyan a su disponibilidad para los países de las Américas.

Misión
Promover la armonización de la reglamentación farmacéutica para las vacunas con vistas a garantizar su calidad, seguridad y eficacia, generando mecanismos más eficientes que contribuyan a su disponibilidad para los países de las Américas.

Objetivos
1. Armonizar los requisitos para la autorización de ensayos clínicos de vacunas en sus diferentes fases y dar seguimiento de su implementación.
2. Armonizar los requisitos para el registro sanitario de las vacunas en las Américas y dar seguimiento a su implementación.
3. Fomentar el intercambio de información y la convergencia y reconocimiento de los sistemas de regulación de vacunas entre las ANRs de la Región.
4. Generar y organizar herramientas y actividades de capacitación dirigidas al personal de las ANRs.
5. Armonizar los requisitos de Buenas Prácticas de Manufactura específicas a vacunas y dar seguimiento a su implementación.
6. Fomentar el establecimiento de sistemas de vigilancia de Eventos Supuestamente Atribuidos a la Vacunación o Inmunización (ESAVI).
7. Identificar otros temas de la reglamentación de vacunas que requieran un tratamiento particular y establecer planes de trabajo para abordarlos.

Miembros del grupo de trabajo en vacunas
Miembros

  • MERCOSUR: Marina Rossi, Argentina
  • COMUNIDAD ANDINA: María Teresa Ibarz, Venezuela
  • SICA: Olga Jacobo Casanueva, Cuba
  • NAFTA: Elwyn Griffiths, Canadá
  • FIFARMA: Marisela Poot, México

Miembros alternos

  • MERCOSUR: María Fernanda Reis e Thees, Brasil
  • COMUNIDAD ANDINA: Leonor Suarez Cozarelli, Ecuador
  • SICA: Martha Escobar, Panamá
  • CARICOM: Stella Harrigin, Trinidad y Tobago
  • FIFARMA: Tarsila Rey, México      

Secretariado (OPS/OMS) 

María Luz Pombo, Washington, DC.  

Planes de trabajo (incluido en el informe de la primera reunión. 2005)

Minutas

1ra. Reunión.  Panamá, junio del 2005
2da. Reunión.  Caracas, diciembre del 2005
3ra. Reunión. Ottawa, junio del 2006

Documentos

Requisitos armonizados para el registro de vacunas en la Región de las Américas y Guía para la preparación de una solicitud de registro sanitario. (2010) 40 p. (sólo en ingles)

Exigences harmonisées pour l'homologation des vaccins Dans la Région des Amériques et Guide d'application  (versión en francés)

Conclusiones y recomendaciones

Conferencia de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica. Informe preliminar de las actividades con sus conclusiones y recomendaciones 

Preliminary Report of the V Pan American Conference on Drug Regulatory Harmonization, Buenos Aires, Argentina. November 2008 
 

Working Group on Biotechnological Products (historical records)

Background

Biotechnological products are medicines produced from animal cell substrates and microbial cultures. Constitutes proteins obtained by the recombinant DNA technique expressed in animal tissues or in microbial life forms, including products obtained through the monoclonal antibody technique. The World Health Organization also uses biotherapeutic products name to refer to biotechnological products.

he development of these products has grown extremely rapidly due to its importance in the prevention, diagnosis, control, and treatment of diseases.  Its regulation faces new challenges in comparison with the regulation of conventional drugs obtained by chemical synthesis. 

In January 2010, the Pan American Network on Drug Regulatory Harmonization Steering Committee (PANDRH) decided to establish a new working group to deal with the specificities of biotechnological products regulation. The decision is included at the minute.

In June 2010, this working group (GT BIO) met for the first time for: designate the main and alternate coordinator, the short- and medium-term objectives, and the establishment of communication mechanisms.  

Mission

Promote the development of the regulation of biotechnological products in the countries of the Americas Region, and to generate more effective and harmonized mechanisms for the regulation of this category of medicines.

1. Compile a list of all regulations related to biotechnological products in place at country level and make them available at the regional level.

2. Establish a glossary of terms to help understand the situation in Member States and to facilitate the further development of related documents.

3. Promote the exchange of information among National Regulatory Authorities of the Region.

4. Identify Regional documents and guidelines for development in the short and medium term and elaborate them as appropriate.

5. Identify other issues related to the regulation of biotechnological products that may require special treatment and establish working plans to address them.

6. Develop tools and training programs to strength capacity building among the National Regulatory Authorities of Members States in relation to the regulatory oversight of biotechnological products and related matters.

Documents and related activities

Working Group on Medicines Registration (historical records)

Mission

To promote and facilitate the harmonization of regionally recognized and appropriate technical criteria for medicines registration to contribute to their quality, safety, efficiency and availability in the Americas.

Objectives

Members of the Working Group on Medicines Registration

Main Members 

  • MERCOSUR: Silvia Boni, Argentina (Main Coordinator)   
  • ANDEAN COMMUNITY: Marcela Pezzani, Chile 
  • SICA: Rodrigo Pérez Massipe, Cuba 
  • CARICOM: Gloria Creary, Jamaica 
  • NAFTA: Justina Molzon, USA 
  • ALIFAR: Veronica Grimoldi, Argentina
  • FIFARMA: Alessandra Nicoli, Brazil   


Alternate Members

  • MERCOSUR: Meiruze Sousa Freitas y Rejane Gomes Silva, Brasil 
  • ANDEAN COMMUNITY: Maria Teresa Ibarz, Venezuela 
  • SICA: Josip De Lora, Panama 
  • CARICOM: Stella Harrigin, Trinidad and Tobago 
  • ALIFAR: Ana María Fallas Quesada, Costa Rica 
  • FIFARMA: Ronoldy Valencia, USA. 

Secretariat (PAHO/WHO) Adriana Ivama.

Working Plans

Minutes

Recommendations 

 

Working Group Pharmacovigilance (historical records)

Mission
 Develop and strengthen Pharmacovigilance through regulatory harmonization activities and proposals that promote the safety and rational use of drugs as a necessary component of public health policies in the Americas.

Objectives

  1. Promote development and circulation of the knowledge, criteria, and methods used in Pharmacovigilance, which should be used in training and educational activities for all actors related to medicines 
  2. Analyze and promote development of harmonization tools to support Pharmacovigilance in the Region
  3. Develop and promote a network that permits exchange of knowledge, communication, and support for decision-making related to Pharmacovigilance
  4. Promote integration of Pharmacovigilance as an essential component of medical programs and public health policies
  5. Promote research on Pharmacovigilance and its circulation, as well as analysis of the impact of Pharmacovigilance on public health, emphasizing patient safety.
    Members
  • MERCOSUR: Salomé Fernández, Uruguay
  • COMUNIDAD ANDINA: Claudia Vaca (Coordinador principal), Colombia
  • SICA: Indira Credidío, Panama
  • CARICOM: Maryam Hinds, Barbados
  • NAFTA: Carmen Becerril, Mexico
  • ALIFAR: Juan Arriola Colmenares, Peru
  • FIFARMA: Ronoldy Valencia, United States
  • Designated by PAHO/WHO: Julián Pérez Peña, Cuba

Alternate Members

  • MERCOSUR: Brazil
  • COMUNIDAD ANDINA: Silvia Alvarez, Peru
  • SICA: Helbert Saénz, Guatemala
  • NAFTA: Heather Sutcliffe
  • ALIFAR: Juan Arriola Colmenares, Peru
  • FIFARMA: Daniel Ciriano, Argentina

Secretariat (PAHO/WHO)

  • José Luis Castro, Washington, D.C.

Conferences

Documents

 

Working Group on Medicines Promotion (historical records)

Mission

  • To promote and harmonize criteria for medicines promotion as a contribution to the rational use, within the scope of health policies in the Americas.

Vision

  • Broaden and strengthen the consciousness and responsibility related to medicines promotion.

Objectives

  • To provide mechanisms and criteria to identify irregularities and demonstrate the most used market strategies of medicines promotion in the American countries. 
  • To provide information and analysis about regulation, implementation and monitoring related to medicines promotion.
  • To promote educational activities and programs related to medicines promotion aimed at health professionals, potential and effective consumers.
  • To evaluate the operation and impact of the activities of the WG.

Members of the Medicine Promotion Working Group

Members

  • MERCOSUR: Brazil Vacant (Coordinator)
  • COMUNIDAD ANDINA: Elvira Tincopa, Peru
  • SICA: Digmara Barban Lores, Cuba
  • CARICOM: Sra. Heather E Carter (Drug Inspector)
  • NAFTA: Margarita Contreras, Mexico
  • ALIFAR: María Angélica Sánchez, Chile
  • FIFARMA: José Manuel Cousiño, Chile
  • Designated by PAHO/WHO: Carlos Fuentes, Nicaragua

Alternate Members

COMUNIDAD ANDINA:Wilma Teran, Bolivia
SICA: Edgar Domínguez, Panama
CARICOM: Mary Louis, Trinidad and Tobago
NAFTA: Margarita Contreras, Mexico
ALIFAR: Laura Castellanos, Dominican Republic
FIFARMA: Héctor Bolaños, Mexico

Secretariat (PAHO/WHO)

  • José Luis Castro, Washington, D.C.

Conferences and Presentations

Technical Documents

Working Plans  (only in Portuguese)

Working Group on Medicines Classification (historical records)


Background  

Mission

  • To harmonize the criteria and their application in the classification of drugs to drugs over the counter (from now on OTC) in the countries of the Americas.

Members 

Main Members

  • MERCOSUR: Tatiana Lowande, Brasil.
  • SICA: Beatriz de la Cruz Pérez, Cuba
  • CARICOM: Pamela Payne-Wilson, Barbados
  • ALIFAR: María Angélica Sánchez, Chile
  • FIFARMA: Hector Bolanos, Mexico


Alternate Members

  • MERCOSUR: Rosa Maria Papale, Argentina
  • SICA: Luis Palma, Panama
  • CARICOM: Mary Louis, Trinidad and Tobago
  • FIFARMA: Marisa Carcione: Argentina

Secretariat (PAHO / WHO)

Juanita Rodriguez, Washington, DC.


Directory 


Minutes 


Documents 

Recommendations 

Working Group on Good Manufacturing Practices (historical records)

Background  

Mission

  • To promote the knowledge and implementation of GMP as a strategy for improving the quality of medicinal drugs in the countries of the Americas. 

Objectives 

  1. To promote democratization in the knowledge of Good Manufacturing Practices through coordinated activities of dissemination, training and specialization aimed at the health authorities, the industrial sector, the academic sector, and other sectors identified as basic to the implementation of GMP.
  2. Development of a Harmonized Guideline or questionnaire for inspections to verify compliance with GMP for the countries of the Americas based on Report 32 of WHO.
  3. Support the regulatory authorities in GMP monitoring inspections.
  4. Raise the level of awareness and support the regulatory authorities in assuming the leadership in the implementation and monitoring of GMP in each country

Members

  • United States - Justina Molzon, Center for Drug Evaluation and Research. FDA  
  • Argentina - Rodolfo Mochetto. Instituto Nacional de Medicamentos. ANMAT 
  • Brasil - Marcelo Vogler Moraes .Inspección y Control de Medicamentos. ANVISA  
  • Canada. - France Dansereau .Head, Inspector Unit 
  • Guatemala - Esmeralda Villagran de Diaz. Ministerio de Salud 
  • Venezuela - Ministerio de Salud. 
  • FIFARMA- Anthony Ventura 
  • Venezuela - Marisela Benaim, ALIFAR 

Experts 

  • Rebeca Rodríguez (SJ-DO/ORA/FDA, District Director); 
  • Millie Barber (SJ-DO/ORA/FDA) 

Secretariat 

  • Pan American Health Organization (PAHO/WHO). United States of America, and Guatemala

Minutes

Documents

Document approved on the V PANDRH Conference:

Working Group on Good Manufacturing Practices  


Presentation of the progress and achievements of the working groups - Good Manufacture Practices (GMP) 

  • Justin Molzon (FDA, USA) 
  • Rodolfo Mochetto (ANMAT, Argentina) 

Regional Guideline for GMP Inspection  

Documents for Public Opinion

Recommendations

 

Traditional Medicines and Herbal Medicines (historical records)

Background 

Mission 

To promote a common understanding on the types of herbal products, definition of terms used, identification of procedures, and minimum requirements for registration of herbal products towards the harmonization of regulation of herbal medicines, within the framework of the Pan American Network of Drug Regulatory Harmonization (PANDRH)

Objetives

  1. To create a network for exchange of information on herbal medicines 
  2. To collect terms used and definitions used for different types of herbal products to come to common understanding and to develop harmonized proposals on herbal medicines
  3. To collect terms used and definitions used for different type of registration, procedures related to herbal products, and to come to a proposal for minimum requirement for each type of registration
  4. To share experiences of regulatory measures to control the quality of herbal medicines
  5. To identify practical mechanisms for harmonizing herbal medicines, particularly regulatory requirements, quality, and standards of herbal medicines.

Members

  • MERCOSUR: Nelida Soria Rey, Paraguay
  • ANDEAN COMMUNITY: Martha Cecilia Rodriguez, Colombia
  • SICA: Benito Soler, Guatemala
  • CARICOM: Princess Osbourne, Jamaica
  • NAFTA: Nancy Richards, Canada
  • ALIFAR: Carlos Silva, Peru


Alternate Members

  • MERCOSUR: Ana Cecília Bezerra de Carvalho, Brasil
  • ANDEAN COMMUNITY: Sandra Carrasco, Bolivia
  • SICA: Pablo Solis, Panama
  • CARICOM: Elmond Chase-Grant, Barbados

Secretariat (PAHO/WHO)
Victoria De Urioste, Washington, DC.
 

Directory 

Working Plan  

Minutes

Documents

Working Group on Substandard/spurious/falsely-labelled/falsified/counterfeit Medical Products (SSFFC) (historical records)

Background

Since its creation in 1999, the GT / CFM has focused on the formulation of proposals for the development of policies and strategies for implementation by countries, development, and promotion of training programs for process optimization of inspection and capacity building/ investigation; and promoting the exchange of information. For more information click here

Mission

  • To promote, facilitate, and motivate implementation of proactive strategies for preventing and fighting medicines counterfeiting and thus contribute to the improvement of health care in our countries in the Americas.

Working Plans

Conferences and Presentations

Technical Documents

 Working Group on Good Laboratory Practice (WG/GLP) (historical records)

This Working Group on Good Laboratory Practice (WG/GLP) was created in June 2005 by recommendation of the Fourth Pan American Conference for Drug Regulatory Harmonization (PARF Network) of PAHO. The formation of this group was based on the excellent work and results obtained up until that time by the external quality control program (PCEC).

The PCEC measures the performance of the official laboratories for control of medicines in the region and sends them blind samples for analysis. The results are evaluated by the United States Pharmacopeia (USP). The medicines controlled to date have been in the PAHO programs on antimalarial drugs, anti-tuberculosis drugs, and HIV/AIDS drugs. The PCEC works under the direction of PAHO/WHO. It has technical assistance and financial support from the USP.

The working group held its first meeting in the city of Panama (1-3 June 2005). At this time, the group was established and defined its mission, objectives, and a 2-year work plan.

Mission 
Strengthen the performance of the official laboratories for control of medicines (LOCM) in the countries of the Region of the Americas through implementation of Good Laboratory Practice, to guarantee the quality of the laboratory test results and facilitate mutual recognition of the results.
 

Objectives

  • Support implementation of GLP in the LOCM1.Preparation and dissemination of educational material for implementation of the WHO GLP (2002)
  • Preparation of a training and continuing education plan
  • Technical support for countries that accept the commitment to implement GLP
  • Establishment of a LOCM network1.Formalization of PCEC
  • Harmonization of reports on results
  • Preparation of a proposal to structure the network
     

Miembros del grupo de trabajo buenas prácticas de laboratorio

Members of the Working Group on Good Laboratory Practice
Main Members: MERCOSUR: Sigrid Mathison, Uruguay; ANDEAN COMMUNITY: Ofelia Villalba, Perú; SICA: Nilka Guerrero, Panama; CARICOM: Lucette Cargill, Jamaica; USP: Damian Cairatti, United States; FIFARMA: Thomas Schultz, United States; Mara Gloria Olate, Chile (Main Coordinator). 

Alternate Members: MERCOSUR: Olga Gruc, Argentina; ANDEAN COMMUNITY: Cecilia Garnica, Bolivia; SICA: Ana Lara Sterling, Cuba; CARICOM: Mrs. C. Alvarez, Trinidad and Tobago.

Secretariat (PAHO/WHO): José M. Parisi, Washington, D.C.

Work Plan
The work plan included the definition and planning of tasks, the assignment of responsibilities, and a time-line for:

  • Interpreting and applying the standard (WHO Report 36)
  • Preparing educational modules and workshops
  • Executing courses on GLP
  • Executing education and training workshops
  • Preparing the self-evaluation guide on GLP
  • Implementing the self-evaluation guide on QCL
  • Evaluating materials provided by USP
  • Preparing sample program for PCEC
  • Preparing documents for the formalization of PCEC
  • Preparing documents for structuring the QCL network
  • Preparing forms for the harmonization of reports and results

 Documents

  • Red PARF Documento Técnico No. 2. OMS Serie de Informes Técnicos, No. 902, 2002. Informe 36, Anexo 3. Buenas prácticas para Laboratorios Nacionales de Control Farmacéutico . (2010) 137 p. (Spanish, English and Portuguese)
  • Red PARF Documento Técnico No. 3. Guía de autoevaluación de buenas prácticas para Laboratorios Nacionales de Control Farmacéutico . (2010) 71 p. (Spanish, English and Portuguese) 
  • Red PARF Documento Técnico No. 4. Estudio sobre las condiciones actuales de los Laboratorios Oficiales de Control de Calidad de Medicamentos (LOCM) en América Latina y el Caribe.  (2010) 45 p. (Spanish, English and Portuguese)
  • Red PARF Documento Técnico No. 6. Documento de Autoevaluación de Buenas Prácticas de Laboratorio (BPL)  (2011) 113 p. (Spanish, English and Portuguese)
  • Rede PARF Documento Técnico No. 9. Boas Práticas da OMS para Laboratórios de Controle de Qualidade de Produtos Farmacêuticos  (2011) 58. (Portuguese)

Course on Good laboratory practices (GLP) for the Official Laboratories for Control of Medicines (LOCM)

Background: The Pan American Network for Pharmaceutical Harmonization (PANDRH Network), through the Technical Working Group on GLP (WG/GLP), developed a proposal for a course on good practices for national pharmaceutical control laboratories. This course has been implemented in several countries of the Region. It will be presented at the Fifth Pan American Conference on Drug Regulatory Harmonization to be held in 2008.

  • Promote use of the WHO recommendations for GLP: Report 36, Annex 3 (Technical Report Series 902, 2002).
  • Improve the performance of the quality control laboratories.
  • Circulate and promote use and correct implementation of the Self-Evaluation Guide on GLP of the PANDRH Network.
  • Increase the communication and exchange of information between the official quality control laboratory, local manufacturers of medicines, and the academic sector.
  • Update the knowledge of the staff members of the Ministries of Public Health and the academic sector regarding to the latest WHO recommendations on GLP.

For more information visit The Pan American Network for Drug Regulatory Harmonization (PANDRH)