Philippines FDA (on 04-October-2022) released the draft “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration”
The purpose of issuing this guidance is to streamline the FDA process and automate the License to Operate (LTO) initial, renewal, and change request system through the FDA eServices Portal System and to update the list of documentation requirements for preliminary license applications.
The guidelines for Drug establishments state that
1. All drug or pharmaceutical establishments shall be under the supervision of a registered pharmacist when operating or opening for business unless otherwise allowed by other pertinent laws or regulations.
2. All entities, whether government or non-government, that regularly procure drugs on a wholesale basis from appropriate FDA-duly licensed drug establishments for distribution to their constituents shall be licensed as a drug distributor.
3. All drug distributors shall not sell directly to the general public or consumers unless they have an LTO as drugstores.
4. All CROs, Sponsors, and other concerned entities shall adhere to existing ethical and scientific quality standards of safety and efficacy in the conduct of clinical trials.
5. No CRO and Sponsor shall be involved in the conduct of clinical trials without a license from the FDA. Likewise, no CRO and Sponsor shall be involved in the conduct of clinical trials without a license from the FDA. Licensed CROs/Sponsors that import/export products subject to clinical trials are no longer required to secure a separate LTO.
Click this LINK to know the List of Requirements for Specific Variation for License to Operate (LTO) and to know about the Requirements for the License to Operate Application click this LINK.
Click this LINK to know more about the Unified Licensing Requirements.
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