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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
European Union
The European Union has streamlined the laws and regulations concerning clinical trials in Member States. Applications for the commencement of clinical trials must be submitted and approved by the Member State and its Ethics Committee. Clinical Trials may not commence until the appropriate Member State and Ethics Committee gives approval. While laws regarding clinical trials do not differ from Member State to Member State, some states have different application procedures (example: Slovak Republic requires all fees paid prior to application and also requires some documents in Slovak). Because of this, procedure guidelines for each individual state should be observed. A detailed list of such guidelines is provided below.
Please note that directive 2001/20/EC applies to EU member states as well as countries in the European Economic Area (EEA). Therefore EudraCT guidance is applicable in Iceland and Norway (EEA but not EU members), in addition to EU member states.
European Commission Laws Regarding Clinical Trials http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol 10_en.htm#chap5
Laws, regulations and administrative provisions for clinical trials on medicinal products for human use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=CELEX:32005L0028:EN:HTML
Medicinal Products for veterinary use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=OJ:L:2009:044:0010:01:EN:HTML
Clinical Trials and Good Clinical Practice (European Medicines Agency document) http://www.emea.europa.eu/pdfs/conferenceflyers/10yearsconf erence/23Clinical%20Trials%20&%20GCP.pdf
European Clinical Trials Database (EudraCT application) https://eudract.emea.europa.eu/eudract/index.do
Specific Countries:
Austria
Procedures for Clinical Trials in Austria http://www.meduniwien.ac.at/ethik/datei/EFGCP_Austria.pdf</ a>
Also see EU laws above
Belgium
Clinical Trials for Human Medicine in Belgium http://www.fagg- afmps.be/en/human_use/medicines/Medicines/research_development/clinical_tr ials/index.jsp
Good Clinical Practice in Belgium http://www.fagg- afmps.be/en/human_use/medicines/Medicines/research_development/good_clinic al_practice/index.jsp
Also see EU laws above
Bulgaria
Bulgarian Regulations for Clinical Trials for Human Medicine http://www.bda.bg/bda_old/web_engl/main.htm
Clinical Trial Notification Form for Bulgaria http://www.bda.bg/bda_old/web_engl/main.htm
Full Documentation on Authorizing Clinical Trials in Bulgaria http://www.bda.bg/bda_old/web_engl/main.htm
Procedures of Clinical Research in Bulgaria http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20Bulgaria%20(revised)%2008-03-01.pdf
Bulgarian Drug Agency (contact, scroll to “Control of Manufacturing and Medicines Trade”, specifically “Clinical Trials”) http://www.bda.bg/bda_old/web_engl/main.htm
Also see EU laws above
Czech Republic
Regulatory Requirements for Clinical Trials Conduct in the Czech Republic http://www.alphapharma.eu/Trials_Czech_Republic.pdf
Also see EU laws above
Denmark
Clinical Trials in Denmark http://www.dkma.dk/1024/visUKLSArtikel.asp? artikelID=1619
Fees for Clinical Trials in Denmark http://www.dkma.dk/1024/visUKLSArtikel.asp? artikelID=10155
Clinical Investigations in Denmark http://www.medicaldevices.dk/1024/visArtikel.uk.mu.asp? artikelID=7650
Danish Legislation for European Directives on Medical Devices http://www.medicaldevices.dk/1024/visArtikel.uk.mu.asp? artikelID=12401
Guidelines and Forms http://www.dkma.dk/1024/visUKLSArtikel.asp? artikelID=1620
Also see EU laws above
Estonia
Clinical Trials in Estonia (conditions and procedure documents)http://www.ravimiamet.ee/222
Also see EU laws above
Finland
Clinical Drug Trials in Finland http://www.nam.fi/pharma_industry/clinical_drug_trials
Clinical Trials on Medicinal Products on Human Subjects in Finland Regulation (document) http://www.nam.fi/instancedata/prime_product_julkaisu/laake laitos/embeds/Clinical_trials_regulation_1_2007_.pdf
Also see EU laws above
France
Procedures for Clinical Research in France http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20France%20(revised)%2008-03-01.pdf
Also see EU laws above
Germany
Clinical Trials in Germany http://www.bmbf.de/en/1173.php
Ethics and Law in Germany http://www.bmbf.de/en/1056.php
German Reference Centre for Ethics in Life Sciences http://www.bmbf.de/en/1056.php
Research Funding in Germany http://www.bmbf.de/en/1398.php
Also see EU laws above
Greece
Clinical Trials http://www.eof.gr/web/guest/clinical
Law for Human Medicines
http://www.eof.gr/web/guest/law
Also see EU laws above
Hungary
Laws and Regulations in Hungary http://www.ogyi.hu/laws_and_regulations/
Clinical Trials in Hungary http://www.ogyi.hu/clinical_trials/
Also see EU laws above
Ireland
Clinical Trials in Ireland http://www.imb.ie/EN/Medicines/Clinical-Trials.aspx
Licensing for Clinical Trials in Ireland http://www.imb.ie/EN/Medicines/Clinical- Trials/Licensing~.aspx
Manufacturing Medicine in Ireland http://www.imb.ie/EN/Medicines/Manufacturing.aspx
Also see EU laws above
Iceland
Clinical Trials in Iceland http://www.imca.is/Clinical_Trials/
Legislation regarding Clinical Trials in Iceland http://www.imca.is/Clinical_Trials/Legislation/
Application for Clinical Trials in Iceland http://www.imca.is/Clinical_Trials/Application/
Please note that as a member of the European Economic Area (EEA), European Directive 2001/20/EC applies to Iceland.
Italy
Procedures for Clinical Research in Italy http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20Italy%20(revised)%2008-03-01.pdf
Italian National Institute of Health* (in Italian) http://www.iss.it/scf1/
Also see EU laws above
Latvia
Clinical Trials in Latvia http://www.vza.gov.lv/index.php? id=381&sa=381&top=333
Also see EU laws above
Lithuania
Clinical Trials in Lithuania http://www.vvkt.lt/index.php?1611190136
Also see EU laws above
Malta
Procedures for Clinical Research in Malta http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20Malta%20(revised)%2008-03-01.pdf
Clinical Trials in Malta (requirements document at bottom of page) http://www.medicinesauthority.gov.mt/clinicaltrials.htm
Clinical Trials Regulations* (in Maltese) http://www.doi.gov.mt/EN/legalnotices/2004/11/LN490.pdf
Also see EU laws above
Netherlands
Procedures for Clinical Research in the Netherlands http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20The%20Netherlands%20(revised)%2008-03-01.pdf
Necessary Documents for Research Involving Human Subjects http://ccmo-online.nl/main.asp? pid=10&sid=62&ssid=65
Also see EU laws above
Norway
Clinical Trials in Norway http://www.legemiddelverket.no/templates/InterPage____16652 .aspx?filterBy=CopyToGeneral
Fees in Norway http://www.legemiddelverket.no/templates/InterPage____25640 .aspx?filterBy=CopyToGeneral
Please note that while Norway is not a member of the European Union,European Directive 2001/20/EC is fully implemented in Norwegian Regulation.
Poland
Procedures for Clinical Research in Poland http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20Poland%20(revised)%2008-03-01.pdf
Clinical Trials in Poland: Forecast http://www.pmrpublications.com/pdf/en_Clinical_trials_in_Po land_20081234963488_.pdf http://74.125.93.104/search? q=cache:_SS11zt56MAJ:www.researchandmarkets.com/reports/649071/clinical_tr ials_in_poland_2008_development.pdf+Clinical+Trials+in+Poland+2008.% 5C&cd=7&hl=en&ct=clnk&gl=us
Also see EU laws above
Portugal
Procedures for Clinical Research in Portugal http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20Portugal%20(revised)%2008-03-01.pdf
Description of Trials in Portugal http://appliedclinicaltrialsonline.findpharma.com/appliedcl inicaltrials/article/articleDetail.jsp?id=168944
INFARMED Publication http://www.infarmed.pt/portal/page/portal/INFARMED/PUBLICAC OES/INFARMED_NOTICIAS/infarmed_noticias_en_05_2005.pdf
Also see EU laws above
Romania
Clinical Trials in Romania http://www.anm.ro/en/html/clinical_trials.html
Also see EU laws above
Slovakia (Slovak Republic)
Information on Clinical Trials in Slovak Republic http://www.sukl.sk/en/clinical-trials/news
Application Procedure for Clinical Trials in Slovak Republic http://www.sukl.sk/en/clinical-trials/procedure-for- submitting-of-clinical-trial-application
State Institute for Drug Control (contact) http://www.sukl.sk/en/clinical-trials/contact
Also see EU laws above
Slovenia
Criteria for Clinical Trials in Slovenia http://www.mz.gov.si/fileadmin/mz.gov.si/pageuploads/mz_dok umenti/delovna_podrocja/zdravstveno_varstvo/kakovost/prirocniki_in_publika cije/pzs_dodatek_1_ang.pdf
Also see EU laws above
Spain
Procedure for Clinical Research in Spain http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20Spain%20(revised)%2008-03-01.pdf
Clinical Trials in Spain* (in English and Spanish) http://www.agemed.es/en/profHumana/ensayosClinicos/home.htm
Application for Clinical Trials in Spain* (in Spanish) http://www.msc.es/profesionales/farmacia/ceic/pdf/resumenEC DIC05.pdf
Also see EU laws above
Sweden
Clinical Trials in Sweden Overview http://www.lakemedelsverket.se/english/product/Medicinal- products/Clinical-trials/
Swedish Medical Product Agency Provisions & Guidelines (medicines for human use) http://www.lakemedelsverket.se/upload/F%c3%b6retag/Humanl% c3%a4kemedel/Klinisk%20pr%c3%b6vning/Provisions%20and%20guidelines%20on% 20clinical%20trials%202003-11.pdf
Swedish Medical Product Agency Provisions & Guidelines (medicines for veterinary use) http://www.lakemedelsverket.se/upload/F%c3%b6retag/Humanl% c3%a4kemedel/Klinisk%20pr%c3%b6vning/Provisions%20and%20guidelines%20on% 20clinical%20trials%201996-17.pdf
Clinical Investigations in Sweden http://www.lakemedelsverket.se/english/product/Medical- devices/Clinical-Investigations/
Swedish Department of Clinical Trials (contact) http://www.lakemedelsverket.se/english/top/Contact- us/Contact-the-Department-of-Clinical-Trials/
Also see EU laws above
Switzerland
Clinical Trials on Medicinal Products in Switzerland http://www.swissmedic.ch/bewilligungen/00089/00282/index.ht ml?lang=en
Legislation for Clinical Trials in Switzerland* (in English and German) http://www.swissmedic.ch/bewilligungen/00089/00476/index.ht ml?lang=en
Necessary Documentation for Clinical Trials in Switzerland http://www.swissmedic.ch/bewilligungen/00089/00478/index.ht ml?lang=en
Fees for Clinical Trials in Switzerland http://www.swissmedic.ch/bewilligungen/00089/00481/index.ht ml?lang=en
Swiss Agency for Therapeutic Products (contact) http://www.swissmedic.ch/bewilligungen/00089/00679/index.ht ml?lang=en
United Kingdom
Guide for Clinical Trials in the UK http://www.mhra.gov.uk/home/groups/es- era/documents/publication/con007504.pdf
Also see EU laws above
Europe (Non-EU Member Countries)
States that are not party to the European Commission directives 2001/20/EC and 2005/28/EC have their own laws and regulations regarding clinical trials. A partial list of these states is available below.
Croatia
Procedures for Clinical Research in Croatia http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20Croatia%20(revised)%2008-03-01.pdf
Also see EU laws above
Russia (Russian Federation)
Procedures for Clinical Trials in Russia http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow% 20Chart%20Russia%20(revised)%2008-03-01.pdf
Clinical Trials in Russia http://appliedclinicaltrialsonline.findpharma.com/appliedcl inicaltrials/data/articlestandard//appliedclinicaltrials/232007/432644/art icle.pdf
Government Agency* (in Russian) http://www.roszdravnadzor.ru/
Ukraine
State Pharmacological Centre of Ukraine http://www.pharma- center.kiev.ua/view/all_information
Law of Ukraine on Medicines http://www.pharma- center.kiev.ua/view/new_doc
State Pharmacological Centre of Ukraine (contact) http://www.pharma-center.kiev.ua/view/contacts
Also see EU laws above