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Revista Colombia Médica
Universidad del Valle - Facultad de Salud
ISSN: 0120-8322 EISSN: 1657-9534
Vol. 40, Num. 4, 2009, pp. 360
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EDITORIAL - The Document of the Americas: Good Clinical Practices for Regulatory Authorities
Revista Colombia Médica, Vol. 40, No. 4, 2009, pp. 361-372
EDITORIAL
The Document of the Americas: Good Clinical Practices for Regulatory Authorities
Ricardo Palacios, MD, PhD
Division of Infectious Diseases, UNIFESP,
Escola Paulista de Medicina,
Director, Meridional R&D,
São Paulo, Brazil
Code Number: rc09051
In 1996, when the Guidelines for Good Clinical Practices of the
International Conference on Harmonization (ICH) were adopted, they
sought to facilitate the actions of regulatory authorities over the
different players of clinical research. These guidelines were
created and incorporated to the legislation of the three regions of the
world (United States, European Union, and Japan) where most of the
drugs, vaccines, biologicals, diagnostic tests, and medical devices are
produced. The regulatory authorities from those three regions are
characterized for their extensive technical capacity to execute their
mission of promoting technological advances and protecting communities.
However, undertaking this task has been difficult, partially because
the ICH Good Clinical Practices defined responsibilities for Ethical
Committees, Sponsors, and Investigators; but the regulatory authorities
did not precise their own responsibilities or indicate how they would
accomplish their duties in that document and, therefore, did not reach
the harmonization of their practices in those subjects.
Certainly, this point is one of the major advances offered by the
Document of the Americas on Good Clinical Practices: helping the
regulatory authorities of the continent to establish a common platform
on how to perform their duties regarding clinical research. The
possibilities that this common regulatory methodology offers to the
authorities from our countries, with greater limitations in budget and
in human resources than their ICH counterparts, are promising: it might
allow unified staff training, conduction of joint inspections and,
even, thinking of a mutual recognition for the actions of the
authorities in each country, as occurred in Europe more than three
decades ago. However, the promises have not been delivered in the
desired extension: despite the March 2005 meeting held in the Dominican
Republic, where the Document of the Americas was published, was held in
March, 2005, it means almost five years ago, few countries, like
Argentina (2007), Brazil (2008), and Colombia (2008) have incorporated
this document into their own regulations.
There are interesting experiences such as the Brazilian federal
government promotion for the creation of centers to lead clinical
research of public health interest in university hospitals, at the same
time that the federal regulatory authority implements the new
regulation on requirements for clinical research centers. In such
experience, the government is not limited to imposing a new standard,
but endorses and actively supports universities and the academic
community as quality references in research. That allows clinical
research to not only become just an additional profitable activity of a
few private players, but also builds capacity to solving regional
problems. Transferring of such experiences might be easier with the
adoption of common platforms within the region.
Having strong regulatory authorities is necessary to move forward from
a provider of volunteers, data, and samples for multinational companies
to becoming a leader in the solutions for our regional health problems,
created from our universities and industries. But the need is even more
urgent: the development of innovative products for our health problems
created either by multinationals or within the region, requires
technically capable interlocutors with close knowledge of the needs of
our community.
The Document of the Americas, pioneer initiative of the Pan American
Network for Drug Regulatory Harmonization (PANDRH), can be the first
step towards a future common regional agency, like the European
Medicine Agency (EMEA); a regional agency that would be able to offer
technical capacity to the member countries and represent the region in
future discussions on research regulation.
All views expressed in this article are those of the author and do not
necessarily represent the views of, and should not be attributed to any
institution.
© Copyright 2009 - Revista Colombia Médica
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