Name of supplement chapter name
42 BioPharm International eBook September 2019 www.biopharminternational.com
Regulatory Sourcebook Resources
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Stock.adobe.com
REGULATORY AND STANDARDS
ORGANIZATIONS
*Information correct as of Sept. 16, 2019
AMERICAS
Brazil
Ministry of Health
saude.gov.br
Brazilian Health Surveillance
Agency (ANVISA)
www.anvisa.gov.br
Canada
Health Canada
www.hc-sc.gc.ca
Mexico
Ministry of Health
www.gob.mx/salud
Federal Commission
for Protection Against
Health Risks
www.gob.mx/cofepris/
United States of America
Food and Drug Administration
www.fda.gov
International
Pharmaceutical Excipients Council
of the Americas
www.ipecamericas.org
United States Pharmacopeia
www.usp.org
ASIA–PACIFIC
Australia
Australian Therapeutic
Goods Administration
www.tga.gov.au
China
Chinese Pharmacopoeia
Commission: Beijing WEIBIAO
Center for Drug Standard
Research & Development
www.chp.org.cn
International Pharmaceutical
Excipients Council of China
www.ipec-china.org
National Institutes for
Food and Drug Control
www.nicpbp.org.cn
State Food and
Drug Administration
eng.sfda.gov.cn
India
Central Drugs Standard
Control Organization
Directorate General
of Health Services
Ministry of Health
and Family Welfare
https://cdsco.gov.in
Department of
Health Research
Indian Council
of Medical Research
www.dhr.gov.in
Japan
International Pharmaceutical
Excipients Council of Japan
(JPEC)
www.jpec.gr.jp
Ministry of Health,
Labour, and Welfare
www.mhlw.go.jp
National Institute
of Health Sciences
www.nihs.go.jp
Pharmaceuticals and Medical
Devices Agency
www.pmda.go.jp
Malaysia
Institute for
Medical Research
www.imr.gov.my
National Pharmaceutical
Regulatory Agency
www.bpfk.gov.my
New Zealand
New Zealand
Medicines and Medical Devices
Safety Authority
www.medsafe.govt.nz
South Korea
Ministry of Food
and Drug Safety
www.mfds.go.kr
The following are some of the notable industry
regulatory and standard setting organizations.
Regulatory and Standard
Setting Organizations
