Country
Key Organizations
Legislation
Regulations
Guideline
China, People’s Republic of
General
1. Ministry of Health (MOH)
Law on Practicing Doctors (June
MOH:
(Mandarin): http://www.moh.gov.cn/
26, 1998), Articles 26 and 37
Interim Measures for Guidelines on
2. Ministry of Science and
(English):http://www.cma.org.c
Ethical Review of Biomedical Research
Technology: http://www.most.cn/
n/ensite/index/HealthcareSystem
Involving Human Subjects (2007)
(English)http://www.most.gov.cn/eng
/20101115/1289827560328_1.ht
(Mandarin):
/index.htm
ml
http://www.moh.gov.cn/publicfiles/business/ht
mlfiles/mohkjjys/s3581/200804/18816.htm
Drugs and Devices
Drugs
State Food and Drug Administration:
Drug Administration Law
1. Implementation Bylaws for the
1. Guideline for HIV Vaccine Research
http://www.sfda.gov.cn/
(2001)
Drug Administration Law (2002)
Technology (2003) (Mandarin):
(English):http://eng.sfda.gov.cn/WS0
(English):http://former.sfda.gov.
(Mandarin)
http://www.sfda.gov.cn/WS01/CL0237/15705.
3/CL0755/
cn/cmsweb/webportal/W456490
(China)http://www.moh.gov.cn/publi
html
37/A48335975.html
cfiles/business/htmlfiles/mohyzs/s357
2/200804/18293.htm
2. Guideline for Vaccine Research
(English):http://www.nicpbp.org.cn/e
Technology (2004) (Mandarin):
n/CL0360/1796.html
http://www.sfda.gov.cn/WS01/CL0055/10307.
2. Chinese Good Clinical Practice
html
(2003) (Mandarin):
3. Guidelines for Ethical Review of
http://www.sfda.gov.cn/WS01/CL005
Clinical Trials of Drugs (2010)
3/24473.html
(Mandarin):
(English):http://www.bioon.com/
http://www.sfda.gov.cn/WS01/CL0050/55655.
drug/chemdrug/243155.shtml
html
3. Rules on the Administration of
Report and Supervision of
Adverse Drug Reactions (2004)
(DOC):\\file1\Office-Research\Re
search Ethics Review
4. Regulation on Drug
Registration (2007)
(Chinese):http://www.sda.gov.cn/W
S01/CL0053/24529.html
(English):http://eng.sfda.gov.cn/WS
03/CL0757/62043.html
5. Qualification and Evaluation of
Clinical Trial Sites (2008)
(Chinese):
http://www.sfda.gov.cn/WS01/CL012
1/29571.html
Devices
State Food and Drug Administration:
Rules on Clinical Research for
http://www.sfda.gov.cn/
Medical Devices (2004)
http://former.sfda.gov.cn/cmsweb
/webportal/W45649039/A566591
91.html
Privacy/Data
Hong Kong:
Protection
Privacy Commissioner for Personal
Personal Data (Privacy)
Data: www.pco.org.hk
Ordinance (1996):
http://www.pco.org.hk/english/ordin
ance/ordfull.html
Research Injury
Ministry of Health (MOH)
Chinese Good Clinical Practice,
MOH:
SFDA:
(Mandarin): http://www.moh.gov.cn/
Article 43 (2003) (Chinese):
1. Interim Measures for
1. Guideline on Medical Device Clinical
State Food and Drug Administration
http://www.sda.gov.cn/WS01/CL00
Guidelines on Ethical Review of
Trials, Article 8 (2004) (Chinese):
(SFDA): http://www.sfda.gov.cn/
53/24473.html
Biomedical Research Involving
http://www.sfda.gov.cn/WS01/CL0053/24475.
Human Subjects, Article 20
html
(2007) (Chinese):
2. Guideline on Vaccine Clinical Trials,
http://www.moh.gov.cn/publicfiles/b
Part 6 (2004) (Chinese):
usiness/htmlfiles/mohkjjys/s3581/200
http://www.sda.gov.cn/WS01/CL0844/10307.h
Genetic Research
804/18816.htm
tml
2. Regulations on Recall of
3. Guideline on Ethical Review of Drug
Medical Devices (Interim),
Clinical Trials,
Article 37 (2011) (Chinese):
Appendix 1, Section 6.10 (2010)
http://www.moh.gov.cn/publicfiles/b
(Chinese):
usiness/htmlfiles/mohzcfgs/s3576/20
http://www.sda.gov.cn/WS01/CL0058/55613.h
1106/51998.htm
tml
1. Ministry of Health (MOH)
MOH and MOST:
(Mandarin): http://www.moh.gov.cn/
Interim Measures for the
2. Ministry of Science and
Administration of Human Genetic
Technology (MOST):
Resources (1998) (Chinese):
http://www.most.cn/
http://www.most.gov.cn/bszn/new/rly
c/wjxz/200512/t20051226_55327.ht
m
Embryos, Stem
1. Ministry of Health (MOH)
MOH:
Cells, and Cloning
(Mandarin): http://www.moh.gov.cn/
1. Ethical Principles and Conduct
2. Ministry of Science and
Norms for Human Assisted
Technology (MOST):
Reproductive Technologies.
http://www.most.cn/
(2003)
2. Regulation on Medical
Technique (2009)
http://www.moh.gov.cn/publicfiles/b
usiness/htmlfiles/zwgkzt/pyzgl/20090
3/39511.htm
MOH and MOST:
Ethical Guideline for Research on
Human Embryo Stem Cells
(2004)
Hong Kong:
Government of the Hong Kong
Human Reproductive Technology
Special Administrative Region
Ordinance, Chapter 561 (2002):
http://www.hklii.org.hk/hk/legis/ord/
561/ (not valid)