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
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
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
Miembros alternos
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
Exigences harmonisées pour l'homologation des vaccins Dans la Région des Amériques et Guide d'application (versión en francés)
Conclusiones y recomendaciones
Working Group on Biotechnological Products (historical records)
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
Alternate Members
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
Alternate Members
Secretariat (PAHO/WHO)
Conferences
Documents
Working Group on Medicines Promotion (historical records)
Mission
Vision
Objectives
Members of the Medicine Promotion Working Group
Members
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)
Conferences and Presentations
Technical Documents
Working Plans (only in Portuguese)
Working Group on Medicines Classification (historical records)
Mission
Members
Main Members
Alternate Members
Secretariat (PAHO / WHO)
Juanita Rodriguez, Washington, DC.
Minutes
Documents
Recommendations
Working Group on Good Manufacturing Practices (historical records)
Mission
Members
Experts
Secretariat
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)
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
Members
Alternate Members
Secretariat (PAHO/WHO)
Victoria De Urioste, Washington, DC.
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
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
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:
Documents
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.