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Links
Regulatory
— International
Global
ICH
Guidelines
www.ich.org/cache/compo/276-254-1.html
ISCT
Legal and Regulatory Affairs Committee
www.celltherapysociety.org/Committees_Working_Groups/Committees/Regulatory_Affairs_North_America.aspx
Global
Harmonisation Taskforce (GHTF)
www.ghtf.org/
Pharmaceutical Inspection Cooperation Scheme; Harmonization of GMP Inspection Standards for Medicinal Products
http://picscheme.org/index.php
Europe
Guidelines
For Stem Cells, Cell Therapy and Xenotransplantation
A worldwide list maintained by the Belgian Biosafety
Clearing-House.
www.biosafety.be/GT/Regulatory/Guidelines_CTXeno.html
Council
of Europe
www.coe.int/T/E/Social_Cohesion/Health/
Guide
to Safety and Quality Assurance for Organs, Tissues
and Cells, 2002
www.coe.int/T/E/Social_Cohesion/Health/Documentation/CDSP-01-34-Eng-draft-Guide-3%20May%2002-DCR1-final.asp#P195_7117
Guide
to the Preparation, Use and Quality Assurance of Blood
Components, 2003
www.coe.int/T/E/Social_Cohesion/Health/Activities/Blood_transfusion/E-Guide%209th%20edition-Final-avec%20index.asp#TopOfPage
Concept
Paper on the Development of a CPMP Points to Consider
on Xenogeneic Cell Therapy
www.emea.eu.int/pdfs/human/bwp/332699en.pdf
Note
for Guidance on the Use of Bovine Serum in the manufacture
of Human Biological Medicinal Products, 2002
www.emea.eu.int/pdfs/human/bwp/179302en.pdf
Note
for Guidance on the Quality, Preclinical, and Clinical
Aspects of Gene Transfer Medicinal Products
www.emea.eu.int/pdfs/human/bwp/308899en.pdf
Gene
Therapy Expert Working Group
www.emea.europa.eu/index/indexh1.htm
JACIE
- Joint Accreditation Committee EBMT-ISCT Europe
www.ebmt.org/8TransplantGuidelines/tguide1.html
European
Commission - Europa
http://europa.eu.int/comm/index_en.htm
European
Agency for the Evaluation of Medicinal Products (EMEA)
www.emea.eu.int
European Commission: Advanced Therapies
http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/index.htm
Europa
- Enterprise - General index on Medical Devices Sector
http://europa.eu.int/comm/enterprise/medical_devices/index.htm
EMEA
and Gene Therapy Medicinal Products Development in the
European Union
www.pubmedcentral.nih.gov/picrender.fcgi?artid=179762&action=stream&blobtype=pdf
Australia
Australia
- Therapeutic Goods Administration, Blood & Tissues
www.tga.gov.au/bt/index.htm
Australia
- National Health and Medical Research Council
www.nhmrc.gov.au/index.htm
Guidelines
for Ethical Review of Research Proposals for Human Somatic
Cell Gene Therapy and Related Therapies
www.nhmrc.gov.au/publications/synopses/e38syn.htm
Proposed
Regulatory Framework for Tissues and Emerging Biological
therapies
http://www.tga.gov.au/bt/prtisreg.htm
Regulatory
Impact Statement for Human Cell, Tissues and Cellular
and Tissue-Based Products
http://www.tga.gov.au/consult/2004/hctpris.htm#pdf
Regulation
of Tissues
http://www.tga.gov.au/bt/tissues.htm
Australian
Code of Good Manufacturing Practice, Human Blood and Tissues
http://www.tga.gov.au/docs/html/gmpbltic.htm
Memorandum
of Understanding on Pharmaceutical GMP, a Cooperative
Arrangement Between The US FDA and TGA
http://www.tga.gov.au/docs/html/fdamou.htm
Austria
Federal
Ministry of Labour, Health and Social Affairs
www.bmsg.gv.at/cms/site/
Belgium
Federal
Public Service (FPS) Health, Food Chain Safety and Environment
https://portal.health.fgov.be
Canada
Canadian
Centre for Occupational Health and Safety - CCOHS
MSDS, FTSS, NIOSHTIC, CHEMINFO, HSELINE, RTECS databases
ccinfoweb.ccohs.ca/
Canadian Standards Association
www.csa-international.org/Default.asp?language=english
Cells,
Tissues, and Organs for Transplantation and Assisted Reproduction:
General Requirements
www.csa-intl.org/onlinestore/GetCatalogItemDetails.asp?mat=2415892&Parent=3244
Lymphohematopoietic
Cells for Transplantation
www.csa-intl.org/onlinestore/GetCatalogItemDetails.asp?mat=2014649&Parent=3347
Tissues
for Transplantation
www.csa-intl.org/onlinestore/GetCatalogItemDetails.asp?mat=2014532&Parent=3346
Health
Canada
www.hc-sc.gc.ca
Therapeutic
Products Directorate
www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/tpd-dpt/index_e.html
China
State
Food and Drug Administration of China (SFDA)
http://eng.sfda.gov.cn/eng/
Ministry
of Health of the People's Republic of China
www.moh.gov.cn
National
Institute for the Control of Pharmaceutical and Biological
Products (China)
www.nicpbp.org.cn
Denmark
Danish
Medicines Agency
www.dkma.dk/1024/visUKLSForside.asp?artikelID=728
Finland
National
Agency for Medicines
(Maintain and promote safety and safe use of medicinal
products, medical devices and blood products)
www.nam.fi/english/about_us/index.html
France
Agence
Francaise de Securite Sanitaire des Produits de Sante
http://agmed.sante.gouv.fr/
Germany
Federal
Ministry of Health
www.bmg.bund.de/cln_040/DE/Home/homepage__node.html__nnn=true
Federal
Institute for Drugs and Medical Devices (BfArM), Bundesinstitut
für Arzneimittel und Medizinprodukte)
Regulates some gene transfer medicinal products (GT-MPs)
www.bfarm.de/cln_042/nn_424276/EN/Home/homepage__node.html__nnn=true
Guidelines
from the German Society of Surgery on Good Professional
Practice for
Tissue Procurement - 2008)
(PDF only)
Paul-Ehrlich-Institut
(PEI)
www.pei.de/cln_048/DE/home/de-node.html?__nnn=true
Regulation
of Gene Transfer Medicinal Products in Germany
Gene therapy and somatic cell therapy products regulated
as gene transfer medicinal products (GT-MPs). Includes
DNA, viral or non-viral vectors and genetically-modified
autologous, allogeneic or xenogeneic cells (used in vivo).
Considered medicinal products (drugs) under German Drug
Law. Vaccines and blood products are regulated by the
Paul-Ehrlich-Institut.
www.pei.de/cln_049/nn_163496/sid_7138601C43B0D7D00516130721966E8E/EN/infos-en/fachkreise-en/genther-fach-en/regulation-genther-en.html?__nnn=true
Greece
National
Drug Organization
www.eof.gr/eof_en/enhome.html
Iceland
Icelandic
Medicines Control Agency (MCA)
www.lyfjastofnun.is/
India
Ministry
of Health & Family Welfare (India)
http://mohfw.nic.in/
Central
Drugs Standard Control Organization
Ministry of Health and Family Welfare
http://cdsco.nic.in/
Regulatory
Requirements of Blood and/or its Components Including
Blood Products
Central Drugs Standard Control Organization
Ministry of Health and Family Welfare
http://cdsco.nic.in/html/guideline.htm
Indonesia
Ministry
of Health
www.depkes.go.id/
Ireland
Irish Medicines
Board
www.imb.ie/
Department
of Health
www.doh.ie/
Italy
Ministry
of Health
www.ministerosalute.it/medicinali/
Japan
Ministry
of Health, Labour and Welfare (MHLW)
mhlw.go.jp/english/
Master bank of the MHLW
National
Institute of Health Sciences (NIHS)
nihs.go.jp/
NIHS evaluates quality, efficacy and safety of prescription
drugs, medical devices, nonprescription drugs and cosmetics.
Division
of Cellular and Gene Therapy Products (NIHS)
nihs.go.jp/cgtp/cgtp/home.html
Guidelines
on Cellular and Gene Therapy Products
www.nihs.go.jp/cgtp/cgtp/guidline/indexg-e.html
Pharmaceuticals
and Medical Devices Evaluation Center, NIHS
nihs.go.jp/pmdec/outline.htm
Korea
Korea Food and
Drug Administration
www.kfda.go.kr/
International
Symposium on the International Harmonization on the Evaluation
of Next Generation Biotechnology Products
www.kfda.go.kr/open_content/english/board/board_view.php?
Korea
Food and Drug Administration Biologics Evaluation Department
www.kfda.go.kr/open_content/english/board/board_view.php?av_seq=10&av_pg=2&board_id=ENG_NEWS&textfield=&keyfield=
Luxembourg
Division
de la Farmacie et des Médicamentes
www.etat.lu/
Netherlands
Medicines
Evaluation Board
www.cbg-meb.nl/
Ministry
of Health, Welfare and Sport
www.minvws.nl/
Dutch
Forum for Biotechnology and Genetics
www.forumbg.nl
New Zealand
Ministry
of Health
www.moh.govt.nz
Human
tissue
www.moh.govt.nz/moh.nsf/indexmh/Human+Tissue-Human+Tissue
Discussion
Document
www.moh.govt.nz/moh.nsf/pagesmh/2963/$File/HumanTissueConsultation.pdf
Overview
and Principles for Human Tissue Legislation
www.moh.govt.nz/moh.nsf/0/40A21654C99717CACC2571230076A57A/$File/human-tissue-cab-paper-1.pdf
Consent
Framework for Organ/Tissue Donation from Deceased People
www.moh.govt.nz/moh.nsf/0/40A21654C99717CACC2571230076A57A/$File/human-tissue-cab-paper-2.pdf
Additional
Matters Relating to the Therapeutic and Non-Therapeutic
Use of Human Tissue
www.moh.govt.nz/moh.nsf/0/40A21654C99717CACC2571230076A57A/$File/human-tissue-cab-paper-3.pdf
Human
Tissue Bill (2006)
www.knowledge-basket.co.nz/gpprint/docs/bills/20060821.txt
Guidelines
on Using Cells from Established Human ES Cell Lines for
Research - discussion document
www.moh.govt.nz/moh.nsf/0/DF32587ABFCA33C5CC2570C800708A24/$File/GuidelinesUsingCells.pdf
Medicines and Medical Devices Safety Authority
www.medsafe.govt.nz/
New
Zealand Bioethics Council
www.bioethics.org.nz
Stem
Cells - Issues in Focus
www.bioethics.org.nz/about-bioethics/issues-in-focus/stem-cells/
Comments to the Ministry of Health on the "Guidelines
on Using Cells from Established Human Embryonic Stem Cell
Lines for Research"
www.bioethics.org.nz/publications/stem-cells-moh-comments-mar06/index.html
Attitudes
to Embryonic Stem Cell Research in New Zealand
www.bioethics.org.nz/publications/stem-cells-attitudes-feb06/index.html
Xenotransplantation
www.bioethics.org.nz/our-work/past/animal-to-human-transplants.html
The
Cultural, Ethical and Spiritual Aspects of Animal-to-Human
Transplantation, Final Report
www.bioethics.org.nz/publications/xeno-final-report-aug05/xeno-report-final-aug05.pdf
Norway
Norwegian
Medicines Agency
www.legemiddelverket.no/templates/InterPage____15421.aspx
Portugal
INFARMED
- The National Pharmacy and Medicines Institute
www.infarmed.pt/en/index.html
Singapore
Health
Sciences Authority
www.hsa.gov.sg
Centre
for Transfusion Medicine - Health Sciences Authority
www.hsa.gov.sg/publish/hsaportal/en/health_services/about_ctm.html
Health Sciences Authority, Centre for Transfusion Medicine
Bone Marrow
Donor Programme (BMDP)
www.bmdp.org/
Singapore
Bioethics Advisory Committee
www.bioethics-singapore.org
Stem Cells
Human
Stem Cell Research Consultation Paper
www.bioethics-singapore.org/old/resources/pdf/Human%20Stem%20Cell%20Consultation.pdf
Ethical,
Legal and Social Issues in Human Stem Cell Research, Reproductive
and Therapeutic Cloning
www.bioethics-singapore.org/old/resources/reports1.html
The
Ethical Position of Singapore on Embryonic Stem Cell Research
www.bioethics-singapore.org/old/resources/pdf/Ethical%20position%20of%20Singapore.pdf
Adult
Stem Cells
www.bioethics-singapore.org/old/resources/pdf/Annex%20E%20-%20ADULT%20STEM%20CELLS.pdf
Umbilical
Cord Stem Cell - Science
www.bioethics-singapore.org/old/resources/pdf/Annex%20E%20-%20UMBILICAL%20CORD%20STEM%20CELL.pdf
Human
Embryonic Stem Cells - Science & Ethics
www.bioethics-singapore.org/old/resources/pdf/Annex%20E%20-%20HUMAN%20EMBRYONIC%20STEM%20CELLS.pdf
Ethical
Considerations in Stem Cell Research
/www.bioethics-singapore.org/old/resources/pdf/Annex%20E%20-%20ETHICAL%20CONSIDERATIONS%20IN%20STEM%20CELL%20RESEARCH.pdf
Somatic
Cell Nuclear Transfer (Cloning) - Science & Ethics
www.bioethics-singapore.org/old/resources/pdf/Annex%20E%20-%20SOMATIC%20CELL%20NUCLEAR%20TRANSFER.pdf
Human Tissue Research
Human
Tissue Research Consultation Paper
www.bioethics-singapore.org/resources/pdf/Human%20Tissue%20Research%20Consultation.pdf
Human
Tissue Research
www.bioethics-singapore.org/old/resources/reports2.html
Human
Tissue for Biomedical Research
www.bioethics-singapore.org/old/resources/pdf/AppendixB-Chapter%20of%20Pathologists.pdf
Testing
of DNA and Tissue in Human Research
www.bioethics-singapore.org/old/resources/pdf/AppendixB-Dr%20Ed%20Liu.pdf
Tissue
Banking for Biomedical Research
www.bioethics-singapore.org/old/resources/pdf/AppendixB-Dr%20Kon.pdf
Spain
Agencia
Española de Medicamentos y Productos Sanitarios
www.agemed.es/en/home.htm
Sweden
Medical Products Agency
www.lakemedelsverket.se/Tpl/StartPage____395.aspx
Switzerland
Swissmedic
- Swiss Agency for Therapeutic Products
www.swissmedic.ch
Taiwan
National
Laboratories of Foods and Drugs
www.nlfd.gov.tw/english/index.aspx
United Kingdom
UK
Department of Health
www.dh.gov.uk/en/index.htm
Medicines
and Healthcare Products Regulatory Agency (MHRA)
www.mhra.gov.uk/
MHRA
- Regulation of Tissue Engineering
www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON009819
MHRA
Committee on Safety of Medicines - Biologicals Subcommittee
www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=455
United
Kingdom Xenotransplantation Interim Regulatory Authority
(UKXIRA)
www.advisorybodies.doh.gov.uk/ukxira/index.htm
Code
of Practice for Tissue Banks, 2001
www.dh.gov.uk/assetRoot/04/03/42/63/04034263.pdf
Guidance
on the Microbiological Safety of Human Organs, Tissues
and Cells used in Transplantation, 2000
www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4005526&chk=iNOtqW
Medical
Devices (Amendment) Regulations 2003 (SI No 1697)
www.opsi.gov.uk/si/si2003/20031697.htm
The
Medical Devices Regulations 2002
www.opsi.gov.uk/si/si2002/20020618.htm
National
Institute for Clinical Excellence (NICE)/Interventional
Procedures Advisory Committee
The Interventional Procedures Advisory Committee of the
National Institute for Clinical Excellence develops guidance
on safety and efficacy of interventional procedures, many
of which involve novel medical devices.
www.nice.org.uk/ip
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