Página 161 - Dimensiones éticas de las regulaciones en salud
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Table 4. International Compilation of Human Subject Protections: Latin America
Country
Key Organizations
Legislation
Regulations
Guidelines
Pan American Health Organization
Drugs
Pan American Health
Organization: http://www.paho.
org/
Good Clinical Practices: Document for the
Americas (2004): http://www.paho.org/
english/ad/ths/ev/GCP-Eng-doct.pdf
Argentina
General
Ministry of Health: http://www.
msal.gov.ar
MOH:
Ministerial Resolution 1490/2007 Approving
the Good Clinical Practice Guideline for Clinical
Research with Human Beings
Cordoba Province:
Ministerial Resolutions No. 00493/2006, No.
00523/06, and No. 00609/06
Neuquén Province:
Law on Biomedical Research in
Human Beings (1997)
Drugs
National:
National Administration
of Medications, Foods, and
Medical Technology (ANMAT)
(Spanish): http://www.anmat.gov.
ar/index.asp
ANMAT:
Provision 5330/97 on General Guidelines for
the Conduct of Clinical Trials (1997) (Spanish):
://infoleg.mecon.gov.ar/infolegInternet/
os/45000-49999/46745/norma.htm
Buenos Aires Province:
Requirements for Health
Research, Law 11.044 (1991)
Privacy/Data
Protection
National Personal Data
Protection Authority (Spanish):
://www.jus.gov.ar/
spersonales/index.html
Personal Data Protection Act
No. 25.326 (2000) (Spanish):
://www.derhuman.jus.gov.ar/
mativa/pdf/LEY_25326.pdf
lish translation:
://www.protecciondedatos.
.ar/law25326.htm
