The PANDRH's technical work support 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 development of a systematic mechanism for priority work areas based on a 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 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 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.
- Terms of Reference. Procedure for the Prioritization of Areas and Selection of Projects. PANDRH 2015 [Spanish - English]
1. Initiative of the National Regulatory Authorities for the joint evaluation of periodic safety update reports (PSURs), risk management plans (RMPs), and periodic benefit-risk evaluation reports (PBRERs). Proponet: Institute of Public Health of Chile, National Health Surveillance Agency (ANVISA-Brazil), and Health Canada [available in pdf Spanish - pdf English ]
2. Assessing CPP requirements for drug registration processes in the Region of the Americas towards more timely access to medicines and more convergent regulatory approaches. Initiator: Latin America Federation of the Pharmaceutical Industry -FIFARMA [available in pdf Spanish - in pdf English ]
3. Foro Permanente de regulación de biológicos de las Américas. Poponentes: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT -Argentina) y Health Canada (conforme al consenso alcanzado en el Taller de Regulación de Biológicos en las Américas- Buenos Aires Octubre 2016) [available in pdf Spanish - English] / Respuesta a comentarios efecutados sobre el Proyecto Foro Permanente de Regualaicón de Biológicos de las Américas. [available in pdf Spanish - in English]
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 in order 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. The WG system was switched to a project based approach on prioritized areas in 2015