ANSWER
REVISED GUIDELINES ON THE UNIFIED LICENSING AND PROCEDURES OF FDA
A revision about the AO 2016-0003 “Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration” was released to further unify the licensing requirements and procedures in FDA in May 2020. Together with the IRR of the RA 11223 “Universal Health Care Law”, this revision aims to provide a network of whole-of-system, whole-of-government, and whole-of-society approach for the development, monitoring, and evaluation of health policies, programs, and plans. The specific FDA Centers and Offices that will handle the respective products are listed below.
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Center for Cosmetics Regulation and Research (CCRR)
– all cosmetic products, household/urban hazardous substances (HHSS), including household/urban pesticides, and toys and childcare articles
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Center for Drug Regulation and Research (CDRR)
– all drugs, including vaccines, biologics, veterinary medicines and animal health products, medical gases, traditional medicine, and herbal medicines
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Center for Device Regulation, Radiation Health and Research (CDRRHR)
– all medical device, radiation-emitting devices, in-vitro diagnostic service and reagents; refurbished medical devices; equipment or devices/systems; and other health-related devices as determined by FDA
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Center for Food Regulation and Research (CFRR)
– all processed food products, food supplements, raw materials, ingredients, and additives for food.
The changes for licensing requirements under the CFRR are clarified in Annex C of this regulation.
Reference
Republic of Philippines Department of Health. (2020). DOH Administrative Order No. 2020-0017 Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003.
