call for papers

CALL FOR PAPERS
Special issue of the
Revista Panamericana de Salud Pública/Pan American Journal of Public Health
Strengthening of Regulatory Systems for Medicines and other
Technologies in the Region of the Americas
The Revista Panamericana de Salud Pública/Pan American Journal of Public Health, published by the Pan American
Health Organization (PAHO/WHO), announces a call for papers for an upcoming special issue on Strengthening of
Regulatory Systems for Medicines and other Technologies, to be published by the end of 2015 with the support of
the US Food and Drug Administration.
Contributions include original research papers, systematic reviews, opinion and analysis, special reports, or brief
communications.
Rationale
Health regulation is regarded as one of public health’s basic functions. Effective regulation of medicines promotes
and protects the public’s health by guaranteeing medicines quality, safety, and efficacy; promoting the adequate
manufacture, storage, and distribution of medicines; facilitating the fight against substandard, spurious, falselylabeled, falsified, or counterfeit (SSFFC) medical products; providing the necessary information to health
professionals and patients so they can use medicines rationally; and ensuring that access to medicines is not
hindered by inefficient regulatory frameworks. Developing a national regulatory system is, hence, a critical
component of a national health system. PAHO/WHO Member States have reaffirmed their commitment to
strengthening regional regulatory capacities for health technologies at PAHO’s 50th Directing Council in 2010 when
they endorsed the Resolution CD50.R9 “Strengthening National Regulatory Authorities for Medicines and
Biologicals”. This issue of the Journal aims at highlighting the progress and remaining challenges that the Region
faces in ensuring access to safe, efficacious and quality-assured medical products.
Main theme and key topics
The main theme of the special issue will be “Strengthening of Regulatory Systems for Medicines and other
Technologies in the Region of the Americas”, addressing:
1.
Core Regulatory Functions and Innovative Operating Models: WHO core regulatory functions for medicines and health
technologies include marketing authorization, import/export control, post-market surveillance, inspections, clinical
trials, and laboratory capacity, among others, and manuscripts submitted for this section could reflect the challenges,
situational analysis and/or innovative regulatory approaches, including risk-based strategies, to improve these core
functions related to all health technologies in the Region. Manuscripts for this section could also explore innovative
models for regulatory systems operations. Ideally, regulatory systems should respond to the needs and specificities of
the national health system and while all regulatory functions are of importance, defining which regulatory functions are
essential and to what depth they should be implemented in relation to national context is critical for developing
sustainable and efficient regulatory systems in developing countries. Defining general principles, cross-cutting elements
and context specific regulatory functions that may come together as alternative and innovative regulatory models will
help build regulatory capacities in countries with limited resources and capacities. Manuscripts submitted under this
topic could include information on novel approaches for transforming, improving and/or developing national regulatory
systems in settings with limited resources and/or capacities including, but not limited to, developing and
implementation of institutional development plans, cooperative approaches based on bilateral or multilateral
arrangements, and the role of non-regulatory bodies (academic, public health, others) in designing, developing and
implementing these regulatory models.
2.
Competencies in Good Regulatory Practices and Regulatory Sciences: In order to perform the essential regulatory
functions, National Regulatory Authorities (NRAs) must have qualified staff capable of applying good regulatory
practices (GRP) and incorporating advances in regulatory-science. NRAs need to institute a human resources policy that
includes the identification of competences that are consistent with their regulatory processes and functions, the
selection of qualified professionals through transparent processes, and the development of incentives that facilitate
individual and institutional development. Moreover, monitoring and evaluating performance in regulatory practices
and the effective implementation of institutional development plans (IDP) remains a challenge for NRAs. Manuscripts
submitted under this topic could include original approaches for promoting the development and application of
regulatory science in decision making process, human resources policies that have proven to increase retention,
efficiency and sustainability, novel approaches for benchmarking, standardizing best practices, defining needs, training
strategies and/or establishing a curriculum for the development of competences in good regulatory practices and
regulatory sciences.
3.
Harmonization, Convergence, Cooperation and Exchange of Experiences, and Reliance: Globalization and trade,
fragmented manufacturing methods and the prevalence of falsified and substandard products are some of the issues
that make it difficult for any country to rely solely on its own regulatory authority and demand increased efforts
towards harmonization, convergence, cooperation and exchange of experiences, and reliance. Manuscripts submitted
under this topic could cover current issues in harmonization and convergence, including membership and industry input
in harmonization forums and successes and challenges in uptake of guidance, as well as novel mechanisms for
cooperation including trends towards forming coalitions and the development and use of information technology tools
for streamlining information exchange. Experiences with third parties to support regulatory systems, reliance on
decisions, and other mechanisms for leveraging the work of others, are welcome topics as well.
4.
Investment Case for Regulatory Systems Strengthening: The evidence base for the value of regulatory systems to
public health, and more broadly, to trade, economic development, and national security, needs to be bolstered.
Although governments may conduct these assessments in the regular course of estimating regulatory policy impact,
there are few studies published in the academic literature. Manuscripts submitted under this topic area could include,
but are not limited to, economic analyses that estimate the costs of failing to develop regulatory systems, the costeffectiveness of specific regulatory interventions, and cost benefit/return on investment analyses for regulatory
systems strengthening activities.
Editorial Committee
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Ricardo Bolaños, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Argentina
Katherine Bond, Food and Drug Administration (FDA), United States
Raquel Child, Ministerio de Salud, Chile
José Vicente Coto, Dirección Nacional de Medicamentos, El Salvador
Rudolph Cummings, Caribbean Community (CARICOM)
Nora Dellepiane, World Health Organization (WHO)
James Fitzgerald, Pan American Health Organization (PAHO/WHO)
Cathy Parker, Health Canada, Canada
Julio Sánchez y Tépoz, Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), México
Ana Paula Soares Juca da Silveira e Silva, Agência Nacional de Vigilância Sanitária (ANVISA), Brasil
Andy Stergachis, University of Washington, United States
Language of Submissions
Papers will be accepted in Spanish, English or Portuguese. The manuscript selection process will follow the journal
peer review procedures.
Publishing Standards
In submitting papers, authors must follow the Instructions to Authors of the Revista Panamericana de Salud
Pública/Pan American Journal of Public Health.
Please indicate in the cover letter that the manuscript is being submitted for the special issue on Strengthening of
Regulatory Systems for Medicines and other Technologies in the Region of the Americas.
Deadline: January 30, 2015
Questions: [email protected]
www.paho.org/journal