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
China
State Food and Drug Administration
The State Food and Drug Administration is directly under the State Council, which is in charge of the comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation. http://eng.sfda.gov.cn/eng/
White Paper: Status Quo of Drug Supervision in China
(SFDA)
http://former.sfda.gov.cn/cmsweb/webportal/W43879541/A64028182.html
- I. Overview of Drug Supply, Quality and Safety
- II. Drug Safety Supervision System and Legal System
- III. Policies and Measures Concerning Drug Safety Supervision
- IV. Supervision of Traditional Chinese Medicine and Folk Medicine
- V. International Exchanges and Cooperation in Drug Safety
Chart: Application and approval procedure for clinical trials
(SFDA)
http://eng.sfda.gov.cn/cmsweb/webportal/W45649089/A64002920.html
Main Clinical Trial Regulations (SFDA)
1) Provisions for Drug Registration http://eng.sfda.gov.cn/cmsweb/webportal/W45649039/A64028429.html
2) Drug Administration Law (2001) http://eng.sfda.gov.cn/cmsweb/webportal/W45649037/A48335975.html#08
3) Regulations for Implementation of the Drug Administration Law of the People's Republic of China (2002) http://eng.sfda.gov.cn/cmsweb/webportal/W45649038/A48335997.html
Laws and regulations applicable to pharmaceuticals (Lehman, Lee & Xu)
English translations of various laws and regulations not found on the SFDA English website. http://www.lehmanlaw.com/resource-centre/laws-and-regulations/pharma.html
India
Central Drugs Standard Control Organization
The Central Drugs Standard Control Organization is the regulatory body in charge of clinical research in India. http://cdsco.nic.in/
Main Clinical Trial Regulations (CDSCO)
1) The Drugs and Cosmetics Act and Rules http://cdsco.nic.in/html/Drugs&CosmeticAct.pdf
2) Schedule Y- Amended version 2005
Requirements and guidelines for permission to import and/or
manufacture of new durgs for sale or to undertake clinical
trials. http://cdsco.nic.in/html/Schedule-Y%20(Amended%20Version-2005)%20original.htm.
- Example of Form 44: Application for permission to import or manufacture new drugs for sale or to undertake clinical trials http://www.indiacorporateadvisor.com/docs/forms/Form%2044.pdf
Good Clinical Practices Guideline: Overview of standards and
procedures in India (CDSCO)
http://cdsco.nic.in/html/GCP1.html
Guidance for Submission of Clinical Trial Application for Evaluating Safety and Efficacy http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf
- I. Submission of Clinical Trial Application for Evaluating Safety and Efficacy
- II. Requirements for permission of New Drugs Approval
- III. Post approval changes in biological products: Quality safety and Efficacy Documents
- IV. Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/Biological Products
Malaysia
National Committee for Clinical Research (NCCR), Ministry of Health
The National Committee for Clinical Research is the government committee responsible for coordinating and encouraging clinical trials in Malaysia. http://www.nccr.gov.my/index.cfm
1) Malaysian Guidelines for Good Clinical Practice (NCCR) http://www.nccr.gov.my/index.cfm?menuid=6&parentid=17
2) Guidelines For Application Of Clinical Trial Import Licence And Clinical Trial Exemption In Malaysia http://www.nccr.gov.my/index.cfm?menuid=10&parentid=17
Philippines
Department of Health
The Department of Health (DOH) is the principal health agency in
the Philippines. It is responsible for ensuring access to basic
public health services to all Filipinos through the provision of
quality health care and regulation of providers of health goods
and services
http://www.doh.gov.ph/
Main Clinical Trial Regulations
1) Administrative Order No. 47-a , series of 2001
Rules and regulations on the registration, including approval and
conduct of clinical trials, and lot or batch release
certification of vaccines and biologic products
http://www.bfad.gov.ph/pdf/RegulatoryGuidance/drug/ao/AO47-As2001.pdf
2) Republic Act No. 3720
Food, Drugs and Devices, and Cosmetic Act
http://www.doh.gov.ph/ra3720
Singapore
Health Science Authority
The Health Sciences Authority (HSA) is a multidisciplinary agency
in health sciences expertise. Our core capabilities encompass
administering the national regulatory frameworks for
pharmaceuticals, complementary medicines, medical devices and
other health products; the running of the national blood bank and
provision of transfusion medicine services; and the provision of
forensic medicine expertise, investigative forensic and
analytical science services.
http://www.hsa.gov.sg/publish/hsaportal/en/home.html
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials.html
Main Clinical Trial Regulations
Conduct of clinical trials in Singapore is regulated by the Medicines Act 1975 and the Medicines (Clinical Trials) (Amendment) Regulations 1998. In addition, the Singapore Guideline for Good Clinical Practice (GCP) has to be observed in the conduct of local clinical trials.
1) Medicines Act 1975
http://statutes.agc.gov.sg/non_version/cgi-bin/cgi_retrieve.pl?actno=REVED-176&doctitle=MEDICINES%20ACT%0A&date=latest&method=part
2) Medicines (Clinical Trials) (Amendment) Regulations 1998: unavailable online http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials/guidelines/ctc_application.html
- The Medicines Act 1975 and the Medicines (Clinical
Trials) (Amendment) Regulations 1998 can be purchased from
SNP Corporation Ltd (Legal Publications):
1 Kim Seng Promenade #18-01
Great World City East Tower
Singapore 237994
Tel (65) 6826-9600
Fax (65) 6820-3341
Email: legalpub@ snpcorp.com
Website: http://www.snpcorp.com/
3) The Singapore Guideline for GCP can be obtained from the
Health Products Regulation Group.
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/contact_info.html
Clinical Trials Branch:
Deputy Director Foo Yang Tong
Tel: 6866 3442
Foo_Yang_Tong@
hsa.gov.sg
Guideline on Application for Clinical Trial Certificate
(CTC)
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/clinical_trials/guidelines/ctc_application.html
Health Products Regulation: Regulatory Guidance
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/regulatory_guidances.print.html?Status=1
SingHealth
The Eastern cluster of public healthcare institutions in
Singapore.
As a site facilitator, “SingHealth Clinical Trials” offers to act
as liaison between the industry (biopharmaceutical companies) and
member institutions
http://www.singhealth.com.sg/Research/ClinicalTrials/index.htm
South Korea
Korea Food and Drug Administration
The KFDA promotes public health by ensuring the safety and
efficacy of foods, pharmaceuticals, medical devices and
cosmetics, and supporting the development of the food and
pharmaceutical industries. http://kfda.go.kr/index3.html
Main Clinical Trial Regulations
Please refer to the free U.S. Commercial Service market research
report Korea: Regulatory Approval for Pharmaceuticals
(11/30/2006), available at http://www.buyusa.gov/healthcare/marketresearch.html.
Regulations on the KFDA website are only available in Korean. Relevant regulations include:
- Pharmaceutical Affairs Act. Enforcement
Ministry of Health & Welfare Act No.363 (Revised on July 3,2006) - Regulation on Product License Application
KFDA Notification 2006-41 (September 11, 2006) - Regulation on Safety and Efficacy Review
KFDA Notification 2003-17 (April 14, 2003) - Regulation on Standard and Testing Methods Review
KFDA Notification 2005-57 (October 17, 2005) - Regulation on Pharmaceutical Equivalence Testing
Management
KFDA Notification 2002-61 (November 22, 2002) - Regulation on Bio-Equivalence Testing Standards
KFDA Notification 2002-60 (November 22, 2002)
Information Resources
1) Global Clinical Trials in Korea: a presentation by In-Soon
Park of the SFDA
http://www.pmda.go.jp/apec2006ph/presen/1013/10.pdf
2) Regulatory Perspectives and Clinical Trial Status in Korea: a
presentation by In-Jin Jang of Seoul National University
Hospital
http://www.pharm.kitasato-u.ac.jp/biostatis/presentation2005/26/Session5/03_IJJang.pdf
3) Korea Pharmaceutical Traders Association
Since its establishment in 1957, KPTA has been striving to
develop pharmaceutical business in international market and we
are proud of its successful results. At present, KPTA stands for
around 400 member companies consist of manufacturers and traders
of pharmaceuticals, cosmetics and medical goods.
http://www.kpta.or.kr/E_main.asp
Thailand
Information from Cliniqal: Offers detailed overview and useful
links
*note, some links on the website do not work
http://www.cliniqal.net/thailand
Thailand Pharmaceutical Update: A report from Tilleke &
Gibbins
http://www.tillekeandgibbins.com/Publications/pdf/LSIPR_2008.pdf
Food and Drug Administration
Protects consumer health by ensuring safety, quality and efficacy
of health products.
http://www.fda.moph.go.th/eng/index.stm
-
Guideline for Good GCP
Thailand has adopted ICH GCP as a guideline to be implemented by investigators throughout the country
http://wwwapp1.fda.moph.go.th/drug/eng/zone_regis/gcp.asp
-
Current Status and Practice in Pharmaceutical Regulations
and Technical Requirements in Thailand
A report from the FDA
http://www.fda.moph.go.th/fda-net/html/product/drug/eng/files/status.pdf
-
Text of a compilation of laws on drugs and food
http://www2.fda.moph.go.th/law/Law_Book.asp?productcd=1&lawid=100005&Contents=1&language=e&lawname=A+Compilation+of+Laws+on+Food+and+Drug&keyword=&keyword2=&codechk=0
Taiwan
Report: Clinical Trials in Taiwan
http://www.cde.org.tw/03center/write/book02_a/Clinical%20Trials%20in%20Taiwan%E2%80%94Regulatory%20Achievement%20and%20Current%20Status.pdf
Department of Health
The Department of Health is in charge of medical issues, health
care, and disease prevention, as well as food, drugs, and
cosmetic management and health insurance affairs. Within
the Department are different Bureaus involved in aspects of
clinical trials and pharmaceuticals.
http://www.doh.gov.tw/EN2006/index_EN.aspx
Bureau of Pharmaceutical Affairs
Pharmaceutical-related laws and regulations
http://www.doh.gov.tw/EN2006/DM/DM1.aspx?class_no=247&level_no=1
- Center for Drug Evaluation
CDE evaluates new drugs and new medical devices for regulatory requirements and offers related consultation services under the delegation and commission of DOH. The principal functions of CDE are: to help Bureau of Pharmaceutical Affairs to set up the review system and enhance the ability to review new drug applications, to support DOH to establish a mechanism in drafting guidelines, and to provide consultation service to local bio-pharmaceutical industries, to upgrade Taiwan’s ability to review the new drug applications of products developed domestically and those have not been approved in any other advanced countries.
http://www.cde.org.tw/eng/default.html
http://www.cde.org.tw/eng/major/tasks.html
Bureau of Food and Drug Analysis
Implements safety regulations of food and drugs
http://www.nlfd.gov.tw/en/index.aspx
The Association of Southeast Asian Nations (ASEAN)
Member Countries include: Brunei Darussalam, Cambodia,
Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore,
Thailand, Vietnam
http://www.aseansec.org/
ASEAN Registration of Pharmaceuticals for Human Use
1) The ASEAN Common Technical Dossier (ACTD)
2) ASEAN Common Technical Requirements (ACTR)
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/western_medicines/guidelines.html