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Prior to the start of
a clinical trial, approval of the clinical trial protocol must be
obtained from the Ethical Review Committee (ERC) of the Ministry of
Public Health (MOPH). In order to be reviewed by the ERC, the protocol
has to be submitted to the Department of Medical Services of the MOPH.
When the approval of the ERC has been received, an application must
be submitted to the New Drug Division of the Food and Drug Administration
(FDA) of Thailand to obtain permission to import the drug for the
clinical trial.
If a medical school is involved in a clinical trial, the protocol must in addition be reviewed and approved by the ERC of the medical school, after the approval of the ERC of the MOPH has been received.
Should a clinical trial involve an AIDS vaccine, the protocol must
first of all be submitted to the Department of Communicable Diseases
Control of the MOPH and reviewed and approved by the National Sub-Committee
of HIV Vaccine of the MOPH before it can be submitted to the ERC(s)
 Health
Care System |
| For the purpose of
establishing a national health care system, a National Health
System Reform Committee (NHSRC) has been set up, which is responsible
for drafting a National Health Act. |
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Authorities |
Food
and Drug Administration (FDA) of Thailand, Ministry of Public Health
Department of Medical Services of the MOPH
Department of Communicable Diseases Control of the MOPH
Ethical Review Committee (ERC) of the MOPH
National Sub-Committee of HIV Vaccine of the MOPH
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THAILAND
