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PANDRH Working Groups

Biotechnological Products Working Group (WG BIO)

 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 1. The World Health Organization also uses biotherapeutic products name to refer to biotechnological products.

The 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.   This and other information appear in this Web site.

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.

Objectives 


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 programmes to strength capacity building among the National Regulatory Authorities of Members States in relation to the regulatory oversight of biotechnological products and related matters.

Main Members

  • MERCOSUR: Patricia Aprea, Argentina (Alternate Coordinator) 
  • ANDEAN COUNTRIES: Hans Vásquez, Peru
  • SICA: Gioconda Castillero, Panama
  • CARICOM: Junia Walcott, Trinidad & Tobago
  • NAFTA: Jian Wang, Canada
  • FIFARMA: José Manuel Cousiño, Chile
  • ALIFAR: Néstor Annibali, Argentina
  • OTHERS: Olga L. Jacobo, Cuba / María T. Ibarz, Venezuela

Alternate Members

  • MERCOSUR: Marcelo Moreira, Brazil (Main Coordinator) 
  • ANDEAN COUNTRIES: Fabiola Muñoz, Chile
  • SICA: Ana Beatriz Cordero, Guatemala
  • CARICOM: Maryam Hinds, Barbados
  • NAFTA: Agnes V. Klein, Canada
  • FIFARMA: Thomas Schreitmueller 
  • ALIFAR: Valentina Carricarte, Argentina

Secretariat (PAHO/WHO): Maria Luz Pombo, Washington D.C.

Documents and related activities

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Working Group Pharmacovigilance

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.

Working Group on Medicines Promotion

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

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

    Working Group on Medicines Classification

    Mission, Objectives and Documents.

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    Working Group on Good Manufacturing Practices

    Presents Mission, objectives and documents.

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    Working Group on Good Clinical Practices

    Working Group on Good Clinical Practices documents, Mission and Objectives.
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    Working Group on Medical Plants

    It presents the mission, objectives and documents.
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    Working Group on Counterfeit Medicines

    Antecedentes
    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 Group on Good Laboratory Practices

    El PCEC mide el desempeño de los Laboratorios Oficiales de Control de Medicamentos de la región, enviándoles muestras ciegas para su análisis cuyos resultados son evaluados por la Farmacopea Norteamericana (USP).

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    PANDRH Bioequivalence Working Group

    Contents: Bioequivalence Working Group´s Mission, objectives, background, recommendations, educational activities, working papers, and information resources.

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    Regional Office for the Americas of the World Health Organization
    525 Twenty-third Street, N.W., Washington, D.C. 20037, United States of America
    Tel.: +1 (202) 974-3000 Fax: +1 (202) 974-3663

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