The Bureau of Food and
Drugs (BFAD) is responsible for drug evaluation, clinical trials and
registration. All clinical trials require clinical trial protocol
approval by the BFAD in accordance with the Administrative Order of
2001. The sponsor must submit a letter of application to the BFAD
Director, together with the clinical trial protocol and other appropriate
documents, as well as details of the composition of the competent
Institutional Ethics Committee.
Compliance with Good Clinical Practice must be ensured.
Before the clinical trial can commence, the sponsor must also obtain
the approval of the appropriate Institutional Ethics Committee as
described in the National Guidelines for Biomedical/Behavioural Research
(2000 edition). The Institutional Ethics Committee has to evaluate
the trial in accordance with the provisions of the Declaration of
Helsinki, and send a statement of approval/disapproval to the applicant
within four weeks after submission of the clinical trial protocol.
The National Ethics Committee, whose members are appointed by the
Philippine Council for Health Research and Development of the Department
of Science and Technology, supervises the performance of Institutional
Ethics Committees.
 Health
Care System |
There is a decentralised
public health system in the Philippines. With the government's
policy of devolution, responsibilities for the management of
primary health care and hospital services were transferred to
Local Government Units.
The private health sector plays a large role in the country's health care.
In 1995 the National Health Insurance Program was created with the aim of providing universal health insurance coverage for all citizens of the Philippines, with at least a basic minimum of health insurance benefits. The Program is to be gradually implemented over a period of about fifteen years. It is intended that the entire population of over 80 million should have access to affordable and adequate health care services. |
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PHILIPPINES
