Please note while every effort has been made to insure the accuracy of the information provided, the links and other content herein should only serve as a basis for further investigation. Laws and regulations can change, and any American company interested in further researching overseas clinical trials should consult with their local Commerce office and the U.S. Embassy in the target country for further information. http://www.buyusa.gov/home/export.html
Pan American Health Organization (PAHO)
The Pan American Health Organization (PAHO) is an international
public health agency with more than 100 years of experience in
working to improve health and living standards of the countries
of the Americas. It serves as the specialized organization for
health of the Inter-American System. It also serves as the
Regional Office for the Americas of the World Health Organization
and enjoys international recognition as part of the United
Nations system.
http://new.paho.org/hq/index.php?lang=en
- Good Clinical Practices: Document of the Americas http://www.paho.org/English/AD/THS/EV/GCP-Eng-doct.pdf
Argentina
Clinical Research in Argentina: Pharmaceutical Industry Information http://www.pharmiweb.com/features/feature.asp?ROW_ID=672
ANMAT: National Administration for Food, Drugs and
Technology http://www.anmat.gov.ar/
*Spanish only
- Powerpoint: Clinical Trials in Argentina 10 Years of Experience http://www.anmat.gov.ar/CURSOSYCONF/2007/Reunion_DIA.pps
Argentina Harmonizes Clinical Trial Regulatory Requirements to
Conform with International Best Practices
http://www.drw-research.com/newsletter/Aug%2008.htm
Brazil
Article Series from ClinPage
The second article describes changes in Brazils regulatory
system.
1) A Quickening Process: Trials Thriving in Brazil
http://www.clinpage.com/article/trials_thriving_in_brazil/C15
2) Faster Launches: Brazil’s Regs
http://www.clinpage.com/article/brazils_regs/C15
3) IRBs Are Next: Brazil’s CRO Association http://www.clinpage.com/article/brazils_cro_association/C15
4) Profiling PPD & MMATISS: A Tale of Two CROs
http://www.clinpage.com/article/a_tale_of_two_cros/C15
National Health Surveillance Agency (Anvisa)
http://www.anvisa.gov.br/eng/index.htm
- Legislation regarding Drugs, Generic Drugs,
Pharmacovigilance, etc.
http://www.anvisa.gov.br/eng/legis/index.htm
Chile
Resources from CORFO, the Chilean Economic Development Agency
“An Emerging Location for Clinical Trials”: Brochure
http://www.investchile.com/rps_corfo_v57/OpenSite/Investchile/Publications/Publications/carga/Chile,%20An%20Emerging%20Location%20For%20Clinical%20Trials.pdf
*Approval Timeframe: 30 days for evaluation and
authorization by the Public Health Institute
-
Clinical Trials Market
http://www.corfo.cl/biotechnology/clinical_trials/clinical.html
- Clinical Research Financial Incentives http://www.corfo.cl/biotechnology/incentives/financial_inves.html
Regulatory Organizations
-
Ministry of Health: Bioethical Unit
The Ministry of Health Bioethical Unit reviews and authorizes all vaccination trials and clinical trials in which three or more Health Services participate.
http://www.minsal.cl/
*Spanish only
-
Scientific Ethics Committee of Health Service
Reviews all clinical and vaccination trials that are conducted within its geographical area.
-
Clinical Trials Unit: Public Health Institute
(ISP)
Reviews and authorizes clinical trials which require entry into the country of non registered products.
http://www.ispch.cl/
*Spanish only
Temporary Entry to Chile Under the Chile-US Free Trade
Agreement: A Guide for US Business Persons
http://www.chileusafta.com/manual%20entrada%20temporal.pdf
Mexico
Secretariat of Health
http://portal.salud.gob.mx/index_eng.html
-
Federal Commission for the Protection against Sanitary Risk
(COFEPRIS)
The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) is a decentralized organ of the Department of Health with technical, administrative and operational autonomy, whose mission is to protect the population against sanitary risks, through sanitary regulation, control and promotion under a single command, which provides unity and homogeneity to the policies which are determined.
http://www.cofepris.gob.mx/wb/cfp/ingles
Reglamento de la Ley General de Salud en Materia de
Investigacion para la Salud 1986
Regulation of the General Law of Health for Research on Health
Related Topics
*text in Spanish
http://www.salud.gob.mx/unidades/cdi/nom/compi/rlgsmis.html
Puerto Rico
Under the Federal Food, Drug and Cosmetic Act, the Commonwealth
of Puerto Rico is defined as a State and follows FDA
regulations.
http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
Pharmaceutical Industry Association of Puerto Rico
The Pharmaceutical Industry Association of Puerto Rico gathers
and represents research-based multinational pharmaceutical and
biotechnology companies with operations in Puerto Rico.
http://www.piapr.com/index.asp
North American Free Trade Agreement (NAFTA)
North American Free Trade Agreement: Table of
Contents
http://www.nafta-sec-alena.org/en/view.aspx?x=343&mtpiID=ALL#mtpi147
- A NAFTA certificate of origin allows medical equipment to be
imported duty-free.
Look under Chapter 5: Customs Procedures, Part Two: Trade in Goods
- NAFTA provides special conditions for the temporary entry of
business persons into Mexico
Look under Chapter Sixteen: Temporary Entry for Business Persons, Part Five: Investment, Service and Related Matters
Central America Free Trade Agreement (CAFTA)
United States-Dominican Republic-Central America Free Trade
Agreement (CAFTA)
Historically, the United States has been the main trading partner
of each of the countries in the agreement—Costa Rica, the
Dominican Republic, El Salvador, Guatemala, Honduras, and
Nicaragua. CAFTA has eliminated all tariffs on 80 percent of
U.S. manufactured goods, with the remainder phased out over a few
years. Importantly, the agreement is not limited to manufactured
goods, but covers virtually every type of trade and commercial
exchange between these countries and the United States. It also
strengthens regulatory standards and environmental protections in
Central America and the Dominican Republic and provides for
independent, outside monitoring.
http://www.caftaintelligencecenter.com/subpages/What_is_CAFTA.asp