Regulatory Agencies lay down the rules and guidelines for conducting the clinical research. The guidelines are by and large the same throughout the world but slight changes are present depending on the laws and legislations in particular countries. The websites given below will give you information regarding the rules in different countries.
| ICH Homepage |
Link: http://www.ich.org
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| Central Drugs Standard Control Organization, India |
Link: http://www.cdsco.nic.in
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| EMEA – European Medicines Evaluation Agency |
Link: http://www.emea.eu.int
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| European Union |
Link: http://europa.eu.int/
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| Australian Department of Health & Ageing |
Link: http://www.health.gov.au
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| Australia Australian Institute of Health & Welfare |
Link: http://www.aihw.gov.au
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| Australian Therapeutic Goods Administration |
Link: http://www.tga.gov.au
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| Belgian Federal Ministry of Social Affairs, Public Health & Environment |
Link: http://minsoc.fgov.be
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| National Drug Institute, Bulgaria |
Link: http://www.bda.bg
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| Health Products & Food Branch, Canada |
Link: http://www.hc-sc.gc.ca/hpfb-dgpsa
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| Standards Council of Canada |
Link: http://www.scc.ca
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| Danish Medicines Agency |
Link: http://www.laegemiddelstyrelsen.dk
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| Estonia State Agency of Medicines |
Link: http://www.sam.ee
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| Ministry of Social Affairs & Health, Finland |
Link: http://www.vn.fi
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| Sanitary Safety of Health Products Agency, France |
Link: http://agmed.sante.gouv.fr
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| German Ministry of Health |
Link: http://www.bmgesundheit.de
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| Federal Institute of Consumer Health, Protection & Veterinary Medicine, Germany |
Link: http://www.bfarm.de/gb_ver
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| Department of Health & Children, Ireland |
Link: http://www.doh.ie
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| Ministry of Health, Labor & Welfare, Japan |
Link: http://www.mhlw.go.jp/english/index.html
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| Food & Drug Administration, Korea |
Link: http://www.kfda.go.kr/
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| Norwegian Board of Health |
Link: http://www.helsetilsynet.no
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| New Zealand Medicines & Medical Devices Safety Authority |
Link: http://www.medsafe.govt.nz
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| Ministry of Health, Poland |
Link: http://www.mz.gov.pl
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| Ministry of Health, Singapore |
Link: http://www.moh.gov.sg/corp/index.do
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| Department of Health, South Africa |
Link: http://www.doh.gov.za
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| Ministry of Health & Consumption, Spain |
Link: http://www.msc.es
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| Medical Products Agency, Sweden |
Link: http://www.mpa.se/eng/index.shtml
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| National Board of Health & Welfare, Sweden |
Link: http://www.sos.se/SOSE/about.htm
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| Federal Office of Public Health, Switzerland |
Link: http://www.bag.admin.ch/index.html?lang=en
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| Department of Health, Taiwan |
Link: http://www.doh.gov.tw/EN2006/index_EN.aspx
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| Ministry of Public, Thailand |
Link: http://eng.moph.go.th
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| Ministry of Health, Welfare & Sport, The Netherlands |
Link: http://www.minvws.nl
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| UK Medical Devices Agency |
Link: http://www.medical-devices.gov.uk
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| UK Department of Health |
Link: http://www.doh.gov.uk
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| ICH GCP Guidelines: |
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this ICH GCP guidance is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions
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| ICH GCP E6 Guidelines |
www.fda.gov/cder/guidance/959fnl.pdf
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| ICH GCP E2A Guidelines |
| http://www.ich.org/LOB/media/MEDIA436.pdf
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| ICH GCP E2B Guidelines |
| http://www.ich.org/LOB/media/MEDIA632.pdf
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| ICH GCP E2C Guidelines |
| http://www.ich.org/LOB/media/MEDIA477.pdf
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| ICH GCP E2D Guidelines |
| ttp://www.ich.org/LOB/media/MEDIA631.pdf |
| ICH GCP E2E Guidelines |
| http://www.ich.org/LOB/media/MEDIA631.pdf
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| International Guidelines for Ethical Review in Epidemiological Studies (1991) |
| http://www.cioms.ch/frame_1991_texts_of_guidelines.htm
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