The Pan American Network for Drug Regulatory Harmonization (PANDRH) is an initiative of the national regulatory authorities within the Region, and PAHO, that supports the processes of pharmaceutical regulatory harmonization in the Americas, within the framework of national and sub-regional health policies and recognizing pre-existing asymmetries.

About PANDRH

Objectives, structure, resolution, and statutes

What is the PANDRH Network?

The Pan American Network for Drug Regulatory Harmonization (PANDRH) started in 1999, and its components are the Pan American Conference on Drug Regulatory Harmonization, the Steering Committee, the Secretariat, and the technical structures needed to implement projects in the agreed strategic areas.

General objetives

PANDRH's general objectives are to:

Strengthen the regulatory functions and systems of the countries of the Region, promoting cooperation and sharing among countries, with the Pan American Health Organization (PAHO), and with other regional and international organizations, civil society, industry associations, and academia.
Develop, approve, and implement common proposals (projects, joint activities, technical documents, guidelines, work plans, etc.) for the regulation of health technologies, considering international guidelines and standards for regulatory convergence.
Develop core competencies aimed at supporting and strengthening good regulatory practices and regulatory science in the Member States with the goal of achieving regulatory convergence in the Region. Encourage the NRAs of the Region to develop and maintain well-structured organizations to achieve effective regulatory functions as an essential part of health systems, in accordance.
The Components of PANDRH are The Pan American Conference on Drug Regulatory Harmonization (PANDRH), the Steering Committee (SC), the Technical Working Groups (WGs) in the areas considered as a priority by the Conference, and the Secretariat.

Consult the Statutes of the Pan American Network for Drug Regulatory Harmonization

PANDRH´s Members

Components of the PANDRH Network

The components of the Pan American Network for Drug Regulatory Harmonization (PANDRH) are the Pan American Conference on Drug Regulatory Harmonization, the Steering Committee, the Secretariat, and the technical structures needed to implement projects in the agreed strategic areas.

Pan American Conferences for Drug Regulatory Harmonization

These conferences constitute a continental forum that deals with drug regulatory harmonization. It includes the presence of all the region's drug regulatory authorities, as well as representation of organisms for economic integration such as CARICOM, MERCOSUR, NAFTA, Latin American Association for Integration (ALADI) and the Andean Community; Academics; representation of regional professional association; and other groups interested from all the continent sub-regions.

The conference constitutes a way to disseminate the decisions on drug regulatory harmonization of global initiatives, such as the International Conference of Drug Regulatory Authorities (ICDRA) and the International Conference on Harmonization (ICH). The PANDRH has become a member of the Global Cooperation Group of the ICH.

The Conference also facilitates the integration of the countries from the continent that do not belong to the sub-region blocks, as is the case of Cuba, the Dominican Republic, and Chile. Its main objective is to support the harmonization processes through the analysis of specific aspects and the adoption of recommendations on priority subjects and harmonized guidelines proposed by the working groups established by the conference itself. Conclusion and recommendations Conference are expected to use by the economic integration groups in its harmonization processes and by all drug regulatory authorities in the countries of the region.

The Steering Committee

The Steering Committee is the decision-making body for the strategic and operational management of the Network, providing guidance for progress on projects and activities, and making recommendations for evaluation and discussion at the Conference.

The Steering Committee is be composed of the Secretariat and of Members and their corresponding Alternates, officially designated to represent each sub-Region of the Region of the Americas, as follows: North America, Central America + Cuba + the Dominican Republic, the Caribbean, the Andean Region, and the Southern Cone.

The Steering Committee will reserve a private space for decision-making by the representatives of the health authorities or Regional regulatory systems/frameworks appointed in accordance with the following:

North America: United States, Canada, and Mexico
Central America + Cuba + Dominican Republic: Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panamá, Cuba, Dominican Republic
Caribbean: Antigua and Barbuda, Bahamas, Barbados, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, St Kitts and Nevis, Saint Lucia, St Vincent and the Grenadines, Suriname, Trinidad, and Tobago
Andean Region: Bolivia (Plurinational State of), Chile, Colombia, Ecuador, Peru, Venezuela (the Bolivarian Republic of)
Southern Cone: Argentina, Brazil, Paraguay, Uruguay

Steering Committee Members will be appointed for a four-year term, ensuring rotation among the countries in each sub-Region and communicating officially to the Secretariat. Rotation will occur at the Pan American Conferences were, to ensure continuity of work, up to three of the five members and alternates should be changed, according to their seniority.

In its discussions and consideration of priorities and relevant subjects, the Steering Committee will invite the participation of representatives of the secretariat of national regulatory authorities of regional reference (NRAr), representatives of the Region's regulatory initiatives/frameworks, and associations of producers of health technologies, as well as FIFARMA and ALIFAR in their role as founding members.

PANDRH´s Steering Committee Members

Below are presented those who will represent the PANDRH Steering Committee until the 10th PANDRH Conference. Their roles and attributes are described in the PANDRH statutes:

SUBREGION

North America
Central America, Cuba, and Dominican Republic
Caribbean
Andean Region
Southern Cone

MAIN COUNTRY

United States
El Salvador
Suriname
Ecuador
Uruguay

ALTERNATIVE COUNTRY

Mexico
Costa Rica
Bahamas
Chile
Paraguay

Observers

SUBREGION

CRS
NRAs
ALIFAR*
FIFARMA*

MAIN COUNTRY

CARPHA
ANMAT
Rubén Abete
Rafael Diaz-Granados

ALTERNATIVE COUNTRY

N/A
N/A
Miguel Maito
María Fernanda Hurtado

*Founding Members

The Secretariat

The Pan American Health Organization (Regional Office of the World Health Organization for the Americas PAHO/WHO) serves as the Secretariat of all the Network's components (Conference, Steering Committee, and technical structures). The Secretariat provides technical and administrative support to PANDRH.

Standards and Procedures

Consult the Statutes of the Pan American Network for Drug Regulatory Harmonization

PANDRH Technical Work

Description

The PANDRH's technical work supports the implementation of the guidelines and decisions of the Pan American Conferences and Steering Committee through the development of projects in the areas identified as priorities by the Network.

During the VII Conference in Ottawa (Canada) in September 2013, the countries approved a PANDRH Strategic Development Plan for the period 2014-2020, where the need for the development of a systematic mechanism for priority work areas based on periodic analysis of the context and the needs of National Regulatory Authorities (NRAs) of each country is expressed.

The procedure should be applied by the Steering Committee of PANDRH for defining the biannual strategic thematic areas, where projects that include activities at achieving the aimed outcome of each of the subject areas defined as priority/strategic will be implemented. These areas should express regulatory functions or cross-cutting themes.

The strategic areas will be defined using the approved prioritization methodology and will be coordinated preferably by a national regulatory authority already designated as NRAs of regional reference (NRAr) based on Resolution CD 50.R9. Each of these areas will be made up of projects that will be proposed by any of the Members of the Network whose approval and implementation will be under the responsibility of the components of the strategic areas.

Participants in each of the strategic areas prioritized include other RNAs of the Region as long as they are interested in the subject, and representatives of manufacturer associations, civil society, and academia, as appropriate, according to the defined area. Each of the projects approved within the priority areas will be coordinated by one of the RNAs participating. An average of nine (9) participating Members by subject area (including RNA and other representatives) and the presentation of projects preceded by terms of reference presented to the Steering Committee which will consist of justification, activities, deadlines, resources, and expected results.

On this basis, the Steering Committee is going to monitor the development of these projects through regular reports by the leaders of the priority areas during face meetings of the PANDRH Steering Committee.

Consult the Terms of Reference. Procedure for the Prioritization of Areas and Selection of Projects PANDRH

Approved projects

PANDRH Technical Working Groups

For information about former PANDRH working groups please visit the PANDRH Technical Working Groups Webpage.

They are 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, WG should have at least one representative for each of the five sub-regional blocs of the Americas.

Academics and other experts can be members of the WG. Its main objectives include the implementation of diagnostic studies in order 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 for the conference for its implementation in the region. The WG system was switched to a project-based approach on prioritized areas in 2015 [Terms of Reference. Procedure for the Prioritization of Areas and Selection of Projects PANDRH]

Documents and publications

Main PANDRH' documents and PAHO/WHO Resolutions

List

Since PANDRH was established, it has produced documents pursuant to PAHO Resolutions and based on the needs of the countries of the Americas, supporting regional technical cooperation initiatives to strengthen national regulatory capacities

Steering Committee Members and Minutes

List

Access here to PANDRH Steering Committee Documents

Conference and publications

Description

The Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH) is held every two or three years. The CPANDRH mission is "to promote drug regulatory harmonization for all aspects of quality, safety, and efficacy of pharmaceutical products as a contribution to the quality of life and health care of the citizens of the Member Countries of the Americas."

Conferences list

Historic documents

They are groups of experts in areas that have been identified as priorities for the drug regulatory harmonization. Members are selected by the Steering Committee and confirmed by the regulatory authorities of the respective countries. Whenever possible, WG should have at least one representative for each of the five sub-regional blocs of the Americas.

Academics and other experts can be members of the WG. Its main objectives include the implementation of diagnostic studies to identify the differences among the countries regarding the implementation of internationals standards and to define the necessary strategies for technical cooperation; analyze international guidelines and prepare harmonized proposal in their areas to be considered for the conference for its implementation in the region.

Publications

During its existence, the TWG have contributed to the dissemination of technical knowledge consistent with the pharmaceutical regulatory harmonization in the Region of the Americas. These works, in major publications, are available in English, Spanish, and Portuguese. Some publications are material for historical reference because they have been updated or are in the process of being revised.