Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration

Other (TBT)

Health care technology (ICS code(s): 11); Food technology (ICS code(s): 67); Chemical technology (ICS code(s): 71)

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11 - Health care technology; 67 - Food technology; 71 - Chemical technology

The regulation aims to introduce technical procedures on inspection and updated list of documentary requirements for the issuance of License to Operate aligned with international standards and automation of FDA licensing application systems. It also intends to repeal Administrative Order No. 2020-0017 (Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing AO No. 2016-0003)._x000D_ The regulation provides the list of updated documentary requirements for LTO applications, in addition to other technical requirements that shall be presented during inspection of the FDA-covered establishments._x000D_ Further, the FDA’s intention to comply with international standards in terms of health shall be institutionalized in the agency’s regulatory process. Hence, compliance with the World Health Organization – Global Benchmarking Tool (WHO-GBT) is necessary.

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