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Republic Act No. 3720, as amended, or the “Food and Drug Administration Act” and its implementing rules and regulation (collectively, the FDA Act), regulates the manufacture, importation, distribution, marketing, advertising and related activities for health products. The FDA Act defines health products as including drugs, medical devices, cosmetics, and health supplements, among others.
Entities that deal with health products are generally required to obtain a license to operate from the Philippine Food and Drug Administration (FDA).
Furthermore, certain health products, such as drugs, certain medical devices, and health supplements, must be registered with the FDA.
Others, such as cosmetics, must only be notified to the FDA.
The labels of health products must also comply with the labelling requirements under FDA regulations.
Clinical trials in the Philippines are regulated by the FDA and the Philippine National Health Research System (PNHRS) through the Philippine Health Research Ethics Board (PHREB).
Clinical trials may be undertaken by sponsors or Contract Research Organizations (CRO). A sponsor refers to an individual, company, institution, organization, or an entity which takes responsibility for the initiation, management, and/or financing of a clinical trial. On the other hand, a CRO refers to a person or an organization (commercial, academic, or other) contracted by a sponsor to perform one of more of the sponsor’s trial-related duties and functions.
Current FDA regulations require a sponsor and the CRO to obtain an LTO from the FDA. Furthermore, clinical trials must be conducted according to an approved clinical trial protocol from the FDA.