PANDRH Members

PANDRH´s Members

The components of 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 the 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 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, Dominican Republic and Chile. Its main objective is to support the harmonization processes through the analysis of specific aspect 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 used by the economic integration groups in its harmonization processes and by all drug regulatory authorities in the countries of the region.  (Read more...)

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 (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 communicated officially to the Secretariat. Rotation will occur at the Pan American Conferences where, in order 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: :

The Secretariat

The Pan American Health Organization (Regional Office of the World Health Organization for the Americas PAHO/WHO) serves as 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

• Statutes of the Pan American Network for Drug Regulatory Harmonization Approved Dec. 2015