Regulatory approval

All trials of unlicensed medicinal products or licensed medicines are likely to be subject to “Competent Authority” approval in most jurisdictions. The competent authority is typically the medicines regulator. For trials conducted in only one country, regulatory approval is only required in the country where the trial is to be conducted. For international trials, approval by the national competent authority in each participating country is required. An exception to this applies in the European Union, where a single approval process applies to trial conduct across all member states.

If you are uncertain whether regulatory approval is required, most competent authorities have a helpline or enquiries service through which advice can be sought, or you can contact established clinical trials centres or trials units for advice, such as members of the International Clinical Trials Centre Network. Country specific information is also available from ClinRegs (an NIH sponsored site listing information on trial regulations in individual countries).

Country (or jurisdiction) specific trial regulation information follows below. This list is not intended to be comprehensive. Updated and/or additional information can be sent to research@theisn.org.

The Therapeutic Goods Administration (TGA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Australia. TGA information on clinical trials approvals can be viewed here.

Contact information
Phone: 1 800 020 653 (free call within Australia) or +61 2 6232 8106
Fax: +61 2 6232 8112
E-mail: clinical.trials@health.gov.au

The National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA))is the regulatory authority responsible for clinical trial oversight, approval, and inspections for drugs to be registered in Brazil. ANVISA grants permission for clinical trials to be conducted in Brazil in accordance with local regulations.

Contact information
ANVISA
Setor de Indústria e Abastecimento (SIA)
Bloco 5, Area Especial 57, Lote 200, Bloco A, Uniap
Brasília (DF)
CEP: 71205-050
Phone: +55 (61) 3462 6700
protocol@anvisa.gov.br

Health Canada (HC) is the competent authority responsible for clinical trial approvals, oversight, and inspections in Canada.

Contact information
Office of Clinical Trials
Therapeutic Products Directorate
5th Floor, Holland Cross, Tower B
Address Locator: 3105A
1600 Scott Street
Ottawa, Ontario
Canada K1A 0K9

Phone: +1 613.941.2132 Fax: +1 613.946.7996 General Enquiries E-mail: OCT_BEC_Enquiries@hc-sc.gc.ca

The National Medical Products Administration (NMPA) (the Chinese name translates as “State Drug Administration”) is the regulatory authority responsible for clinical trial oversight, approval, and inspections for drugs to be registered in China. Previously known as the China Food and Drug Administration (CFDA), the NMPA grants permission for clinical trials to be conducted in China.

Contact information National Medical Products Administration
No. 1 North Luyuan, Exhibition Road
Xicheng District
Beijing 100037
P.R. China
Phone: +86 68313344
Website: http://www.nmpa.gov.cn

Submissions can now be made via the Common European Submissions Portal (CESP). CESP also lists the contact for relevant National competent authorities in Europe.

The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for clinical trial oversight, approval, and inspections in India.

Contact information
Drugs Controller General of India
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
FDA Bhavan
ITO
Kotla Road
New Delhi 110002
India
Phone: +91-11-23216367 / 23236975
Fax: +91-11-23236973
E-mail: dci@nic.in

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority responsible for clinical trial approvals and other services.

Contact information
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan
Email form: https://www.pmda.go.jp/english/0002.html

Kenya’s Pharmacy and Poisons Board (PPB) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. In 2012, the PPB appointed an Expert Committee on Clinical Trials (ECCT) to evaluate all matters relating to clinical trials and to grant permission for clinical trials to be conducted in Kenya.

Contact information Pharmacy and Poisons Board
P.O. Box 27663 – 00506
Nairobi
Lenana Road Opp. DOD
Kenya
Phone: +254 (720) 608811 or +254 (733) 884411
General Email: enquiries@pharmacyboardkenya.org

The Pharmacy, Medicines and Poisons Board (PMPB) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Malawi.

Contact information
Pharmacy, Medicines and Poisons Board
PMPB Building
PO Box 30241
Chilambula Road
Lilongwe 3, Malawi
Phone: +265 01 75 5165
Fax: +265 01 755 204
Email: info@pmpb.mw

The Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS)) is the regulatory authority responsible for approving all clinical studies for the use of health resources, procedures, or experimental activities in human beings and/or their biological samples, for scientific research purposes. Information on approvals can be obtained here.

Contact Information
COFEPRIS
Centro Integral de Servicios
Oklahoma Street No. 14
Colony Napoles
Delegation Benito Juárez
Mexico City
CP 03810
Phone: Domestic General Inquiries: +52 01-800-033-5050
Phone: International General Inquiries: +52 01-800-033-5050 and +52 (55) 5531-1643
Email: contactociudadano@cofepris.gob.mx or contacto@cofepris.gob.mx

Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. The INS, through the General Office for Research and Technology Transfer (Oficina General de Investigación y Transferencia Tecnológica (OGITT)), grants permission for clinical trials to be conducted in Peru.

Contact Information
Instituto Nacional de Salud
Oficina General de Investigación y Transferencia Tecnológica
Capac Yupanqui 1400
Jesus María
Lima 11
Perú
Phone: +51 1 748 1111
Clinical Trial Phone: +51 1 748 1111 (Ext. 2191)
Clinical Trial Email: consultaensayos@ins.gob.pe

The South African Health Products Regulatory Authority (SAHPRA) (formerly the Medicines Control Council (MCC)) is the regulatory authority overseeing medicines and clinical research, as well as medical devices and radiation safety.

Contact information:
South African Health Products Regulatory Authority
Private Bag X828
Pretoria
0001
South Africa
New Clinical Trial Applications (CTA) and Responses to Reviews of CTAs: ctcresponses@sahpra.org.za

The Thai Food and Drug Administration (Thai FDA) is the regulatory authority responsible for controlling the import of drugs for research purposes, and also uses this authority to indirectly regulate drug clinical trials in humans.

Contact information:
Bureau of Drug Control
Food and Drug Administration
Ministry of Public Health
88/24 Tiwanon Road
Mueang District
Nonthaburi 11000
Thailand
Phone: Int. +66 2 590-7171 or Int. +66 2 590-7160
Fax: Int. +66 2 590-7170, +66 2 591-8390, or +66 2 591-8489
Email: drug@fda.moph.go.th

The National Drug Authority (NDA) is the regulatory authority responsible for clinical trial approval and inspections in Uganda. The NDA grants permission for clinical trials to be conducted in Uganda.

Contact information:
National Drug Authority
Secretariat Office Kampala
Plot 19 Lumumba Avenue
P.O. Box 23096
Kampala, Uganda
Phone: +256 417 788 100/1, +256 417 788 124 / 041 788 129
Fax: +256 41 255758
Email: ndaug@nda.or.ug

The Medicines and Healthcare Regulatory Authority (MHRA) is the competent authority for clinical trial approvals, oversight and inspections in the United Kingdom.

Contact information:
MHRA
10 South Colonnade
Canary Wharf
LONDON
E14 4PU
UK
Phone: +44 020-3080-6000
Fax: +44 0203-118-9803
General Email: info@mhra.gov.uk
*Clinical Research Office:
Email: clintrialhelpline@mhra.gov.uk
Phone: +44 020-3080-6456

The Food & Drug Administration (FDA) is the regulatory authority that regulates clinical investigations of medical products in the United States (US).

Contact information:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Telephone: +1 (888) 463-6332
Email: druginfo@fda.hhs.gov

Vietnam’s Ministry of Health (MOH) is the regulatory authority responsible for clinical trial approvals, registration, oversight, and inspections. The MOH grants permission for clinical trials to be conducted in Vietnam.

Contact information: Ministry of Health
Administration of Science, Technology and Training
138B Giang Vo St.
Ba Dinh District
Hanoi City, Vietnam
Phone: +84 04.33846688
Fax: +84 04.32373236
Email: cuck2dt@moh.gov.vn

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Fax: +1 908 272 7101
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