The Philippine Food and Drug Administration (FDA) has published an administrative order to update the license-to-operate (LTO) rules, requirements and procedures for drug and medical device companies.
Companies that make, import, export, sell and otherwise handle medicines, medical devices and other health products must secure a LTO from FDA. FDA revised its guidelines on issuing, renewing and changing LTOs in 2020 to adopt a more harmonized licensing system across all health product establishments.
Now, the agency is repealing the order it published in 2020 and establishing new rules, requirements and procedures. FDA said it needs to update the list of technical and documentary requirements. Companies need to comply with the requirements for FDA’s evaluation of technical compliance and the inspection of covered establishments to ensure the safety of their health products.
FDA is extending the validity of LTOs as part of the update. The 2020 order said FDA would state the duration of the validity of LTOs in other documents. FDA’s website says initial and renewed LTOs last for 2 years and 5 years, respectively. The latest order extends the validity of initial and renewed LTOs to 6 years for medium-sized enterprises and 12 years for large enterprises. Micro and small enterprises get 3 years for initial LTOs and 6 years for renewed licenses.
The agency also framed the guidance as part of its work to address “emerging concerns,” stay abreast of internationally accepted standards and strengthen its regulatory capacity and licensing, inspection and monitoring capabilities. FDA aims to integrate information and communication technology to “maximize a focus on risks, promoting faster coordination and information sharing.”
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